Regulatory milestones approvals, filings & regulatory actions · 16 recorded
Milestone
Jurisdiction
Brand
Indication
Date
Sentence it was read from
FiledAlzheimer disease12 milestones
Filed
US (FDA)
LEQEMBI IQLIK
Alzheimer disease
2025-11-25
“completed the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb” biogen.com ↗
“the U.S. Food and Drug Administration (FDA) has accepted for review Eisai’s Supplemental Biologics License Application (sBLA) for lecanemab-irmb” biogen.com ↗
Filed
US (FDA)
LEQEMBI
Alzheimer disease
2025-09-02
“initiated the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb” biogen.com ↗
Filed
US (FDA)
LEQEMBI
Alzheimer disease
2024-10-31
“Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb” biogen.com ↗
Rejected
Other
—
Alzheimer disease
2024-10-16
“initial decision not to register the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab” biogen.com ↗
“In response to February 2025 TGA decision not to approve lecanemab as a treatment for people with early AD” biogen.com ↗
Filed
Other
Leqembi
Alzheimer disease
2024-10-02
“an application for Alzheimer’s disease treatment lecanemab (generic name, global brand name: Leqembi ® ) has been submitted for review in Saudi Arabia.” eisai.com ↗
Filed
US (FDA)
LEQEMBI
Alzheimer disease
2024-03-31
“In July 2022, the U.S. Food and Drug Administration (FDA) accepted Eisai’s Biologics License Application (BLA) for lecanemab under the accelerated approval pathway” biogen.com ↗
“In September 2021, Eisai initiated a rolling submission to the FDA of a Biologics License Application (BLA) for lecanemab under the Accelerated Approval pathway” eisai.com ↗
“Eisai submitted to the FDA a Supplemental Biologics License Application (sBLA) for monthly LEQEMBI intravenous (IV) maintenance dosing in March 2024.” biogen.com ↗
“Eisai submitted to the U.S. Food and Drug Administration (FDA) a Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb” biogen.com ↗
“Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA)” biogen.com ↗
“Eisai submitted the BLA through the FDA’s Accelerated Approval Pathway” biogen.com ↗
Filed
Other
—
Alzheimer disease
2023-03-31
“In Canada, Eisai submitted a New Drug Submission (NDS) to Health Canada on March 31, 2023” eisai.com ↗
“Health Canada has accepted a New Drug Submission (NDS) for lecanemab” biogen.com ↗
Filed
US (FDA)
LEQEMBI
Alzheimer disease
2023-03-03
“On March 3, 2023, the FDA accepted Eisai’s sBLA based on the Clarity AD clinical data” biogen.com ↗
Filed
EU (EMA)
LEQEMBI
Alzheimer disease
2023-01-09
“marketing authorization application (MAA) of lecanemab (generic name, brand name: LEQEMBI ® ), which is currently under review by the European Medicines Agency (EMA)” eisai.com ↗
“In Europe, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023” eisai.com ↗
“Eisai has also submitted applications for approval of lecanemab in 10 countries and regions, including the European Union (EU).” eisai.com ↗
“Eisai has also submitted applications for approval of lecanemab in 10 countries and regions, including the European Union.” biogen.com ↗
Filed
US (FDA)
LEQEMBI™
Alzheimer disease
2023-01-06
“Eisai has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) supporting the conversion of the Accelerated Approval of LEQEMBI™” biogen.com ↗
Filed
China (NMPA)
—
Alzheimer disease
2022-12-22
“Eisai has initiated submission of data for Biologics License Application (BLA) to the National Medical Products Administration (NMPA) of China for lecanemab” biogen.com ↗
“initiated submission of data for Biologics License Application (BLA) to the National Medical Products Administration (NMPA) of China for lecanemab” bioarctic.com ↗
“Eisai has also submitted applications for approval of lecanemab in Japan, EU, China, Canada, Great Britain and South Korea.” biogen.com ↗
“In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China.” eisai.com ↗
Filed
US (FDA)
—
Alzheimer disease
2021-09-27
“initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab” bioarctic.com ↗
“Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA)” biogen.com ↗
“Eisai completed lecanemab’s rolling submission of a Biologics License Application (BLA) for the treatment of early AD to the FDA” eisai.com ↗
Filed
US (FDA)
—
familial Alzheimer-like prion disease
2021-09-27
“Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401)” biogen.com ↗
“Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab” biogen.com ↗
With this approval, LEQEMBI treatment now offers a new option of once-weekly SC administration at home*, in addition to intravenous (IV) administration every two weeks in a hospital setting.
Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced today that Canada’s Drug Agency (CDA-AMC) has issued a final recommendation supporting public reimbursement of LEQEMBI® (lecanemab) for eligible patients in Canada living with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (early AD).
Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced today that Canada’s Drug Agency (CDA-AMC) has issued a final recommendation supporting public reimbursement of LEQEMBI ® (lecanemab) for eligible patients in Canada living with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (early AD).
Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a once‑weekly lecanemab‑irmb subcutaneous injection (U.S. brand name: LEQEMBI IQLIK ® ) as an initiation dose for the treatment of early Alzheimer’s disease.
Results showed that once-weekly 500 mg SC-AI achieved drug exposure similar to the approved intravenous (IV) initiation regimen (10 mg/kg every two weeks), supporting the expectation of similar clinical efficacy and safety, independent of the route of administration.
Results showed that once-weekly 500 mg SC-AI achieved drug exposure similar to the approved intravenous (IV) initiation regimen (10 mg/kg every two weeks), supporting the expectation of similar clinical efficacy and safety, independent of the route of administration.
As part of the ongoing review process, the agency requested additional information and has determined that it constituted a major amendment to the sBLA, extending the PDUFA date to allow sufficient time for a full review of the additional materials.
Ninety-four percent of patients who completed 18 months of lecanemab treatment in the Phase III Clarity AD chose to continue maintenance treatment by enrolling in the subsequent open-label, long-term extension (OLE) study.
The findings represent the results from a large-scale clinical study demonstrating, for the first time, that binding of lecanemab to PF can be measured in CSF, enabling further understanding of how lecanemab slows Alzheimer’s disease (AD) progression.
Long-term LEQEMBI treatment suggests potential to delay disease progression from Mild Cognitive Impairment (MCI) to moderate Alzheimer’s disease by up to 8.3 years in low-amyloid group who started treatment at an early stage
The findings represent the results from a large-scale clinical study demonstrating, for the first time, that binding of lecanemab to PF can be measured in CSF, enabling further understanding of how lecanemab slows Alzheimer’s disease (AD) progression.
announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI ® ” (generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.
LEQEMBI ® ” (brand name in China: “乐意保 ® ”, generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the National Medical Products Administration (NMPA) in China.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI ® IQLIK TM , pronounced “I Click”) for maintenance dosing.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI ® IQLIK™, pronounced "I Click") for maintenance dosing.
Lecanemab subcutaneous autoinjector has the potential to become a new expanded treatment option for patients with early Alzheimer’s disease, their care partners and healthcare professionals, with results showing a comparable efficacy and safety profile to the intravenous formulation
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the European Commission (EC) has granted the amyloid-beta (Aβ) monoclonal antibody Leqembi ® (lecanemab) Marketing Authorization (MA) in the European Union (EU).
The European Commission (EC) has granted the amyloid-beta (Aβ) monoclonal antibody Leqembi ® (lecanemab) Marketing Authorization (MA) in the European Union (EU).
Following the EC deliberations on the MAA in its Standing Committee in March 2025, the Appeal Committee has conducted its deliberations and did not reach a decision.
Following the EC deliberations on the MAA in its Standing Committee in March 2025, the Appeal Committee has conducted its deliberations and did not reach a decision.
The EC announced that it has deliberated on the MAA in its Standing Committee and, based on the results of those deliberations, has referred the decision to the Appeal Committee in accordance with the EC review process.
The EC announced that it has deliberated on the MAA in its Standing Committee and, based on the results of those deliberations, has referred the decision to the Appeal Committee in accordance with the EC review process.
the Therapeutic Goods Administration (TGA) of Australia has confirmed the initial decision to decline the approval of humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab
As part of its decision-making process, the European Commission (EC) has asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion in November 2024 and whether this may require an update of the opinion, and to consider whether the wording of the risk minimization measures in the opinion is clear enough to ensure correct implementation.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for lecanemab-irmb (U.S. brand name: LEQEMBI ® ) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing.
Furthermore, this research identified that the concentration of Lec-PF in cerebrospinal fluid is significantly correlated with biomarkers reflecting neurodegeneration.
announced today a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the amyloid-beta (Aβ) monoclonal antibody lecanemab as a treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4)* non-carriers or heterozygotes with confirmed amyloid pathology.
Eisai will request a reconsideration of this decision under Section 60* of the Therapeutic Goods Act within 90 days to make lecanemab available for eligible people living with early AD in Australia.
Eisai will request a reconsideration of this decision under Section 60* of the Therapeutic Goods Act within 90 days to make lecanemab available for eligible people living with early AD in Australia.
Moreover, an application for Alzheimer’s disease treatment lecanemab (generic name, global brand name: Leqembi ® ) has been submitted for review in Saudi Arabia.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the humanized amyloid-beta (Aβ) monoclonal antibody “Leqembi ® ” (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI ® ” (lecanemab) for the treatment of Alzheimer’s disease (AD).
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI ® ” (lecanemab) for the treatment of Alzheimer’s disease (AD).
Three Years of Continuous Lecanemab Treatment Reduced Clinical Decline by -0.95 on CDR-SB Showing Continued Clinically and Personally Meaningful Benefit for Early AD Patients
Three Years of Continuous Lecanemab Treatment Reduced Clinical Decline by -0.95 on CDR-SB Showing Continued Clinically and Personally Meaningful Benefit for Early AD Patients
We are extremely disappointed by the CHMP’s negative opinion and understand that this may also be disappointing for the wider Alzheimer’s disease (AD) community.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Department of Health in Hong Kong has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI ® ” (brand name in Hong Kong: “樂意保 ® ”, generic name: lecanemab) for treatment of Alzheimer’s disease (AD).
For this reason, the EMA has decided to annul the advice obtained at the SAG-N (Scientific Advisory Group on Neurology) meeting for lecanemab held on March 11, 2024.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI ® ” (brand name in China: “乐意保 ® ”, generic name: lecanemab-irmb) has been approved in China as a treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia.
China is the third country to grant marketing approval, following the traditional approval in the U.S. in July 2023 and Japanese approval in September 2023.
Weekly subcutaneous (SC) administration showed 14% greater amyloid plaque removal than biweekly IV administration as suggested in a preliminary analysis using amyloid PET at 6 months of treatment.
Weekly subcutaneous (SC) administration showed 14% greater amyloid plaque removal than biweekly IV administration as suggested in a preliminary analysis using amyloid PET at 6 months of treatment.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI ® Intravenous Infusion” (200 mg, 500mg, lecanemab) has been approved in Japan as a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD).
The unanimous decision by the panel of independent experts was based on the supplementary Biologics License Application (sBLA) which includes data from Eisai’s large global confirmatory Phase 3 Clarity AD trial.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that Eisai has submitted a marketing authorization application for lecanemab (brand name in the U.S.: LEQEMBI®), an investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain, to the Ministry of Food and Drug Safety (MFDS) in South Korea.
The paper concluded that lecanemab treatment would improve health and humanistic (quality of life) outcomes and reduce economic burden for individuals with early AD and their caregivers in Japan.
The study showed that the estimated lifetime risk of disease progression to mild, moderate, and severe AD dementia could potentially be reduced by 7.5%, 13.7% and 8.8%, respectively, in patients who received lecanemab+SoC, compared to those who received SoC alone.
Eisai presented new analyses on amyloid-related imaging abnormalities (ARIA) with the use of antiplatelet and anticoagulant medications, isolated ARIA-H, and caregiver burden and health-related quality of life (QOL)
the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.
the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.
an application for manufacturing and marketing approval for lecanemab (generic name, U.S. brand name: LEQEMBI™), an anti-amyloid-β (Aβ) protofibril * antibody, in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare (MHLW).
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that Eisai has initiated submission of data for Biologics License Application (BLA) to the National Medical Products Administration (NMPA) of China for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody.
Eisai announced today that they have initiated submission of data for Biologics License Application (BLA) to the National Medical Products Administration (NMPA) of China for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody.
The rapid publication of the Clarity AD study results demonstrates Eisai's strong commitment to trust and transparency based on Eisai’s human health care mission.
Lecanemab met the primary endpoint (CDR-SB: Clinical Dementia Rating-Sum of Boxes*) and all key secondary endpoints with highly statistically significant results.
Lecanemab met the primary endpoint (CDR-SB: Clinical Dementia Rating-Sum of Boxes*) and all key secondary endpoints with highly statistically significant results.
Eisai’s application, which was completed in early May 2022, has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023.
Eisai’s application, which was completed in early May 2022, has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date on January 6, 2023.
Eisai’s application, which was completed in early May 2022, has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023.
The preliminary results of this model-based simulation could possibly translate into additional quality-adjusted life years (QALY**) and reduction in the formal and informal care costs***.
In conjunction with the completed regulatory filing to the FDA announced today, and the subsequent acceptance by the FDA of the file, BioArctic is entitled to a milestone of MEUR 15.
It was shown that the estimated lifetime risk of disease progression to mild, moderate, and severe AD dementia from baseline could potentially be reduced by 7%, 13% and 10% in lecanemab+SoC, respectively, compared to SoC.
In this simulation, lecanemab treatment is estimated to slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of the disease.
We respect that the Centers for Medicare and Medicaid Services (CMS) has committed to quickly reconsider the National Coverage Determination (NCD) once an anti-amyloid drug for the treatment of AD has met the Coverage with Evidence Development (CED) requirements with quality evidence.
New data on blood biomarkers of amyloid and p-tau from the Phase 2b study in early Alzheimer’s disease was presented, as well as preliminary results from its ongoing open-label extension study.
Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan
BioArctic AB:s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401).
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today that lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today results of new clinical, biomarker and safety assessments of brain amyloid reduction and five-year clinical status of people living with early Alzheimer’s disease (AD) from the lecanemab Phase 2b 201 and the open-label extension (OLE) studies.
Six sensitivity analyses across four statistical models (mixed model for repeated measures, disease progression model, natural cubic spline model, and quadratic mixed model) showed consistent positive lecanemab treatment effects for ADCOMS, CDR-SB and ADAS-Cog14 at 18 months.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") announced today results of new clinical, biomarker and safety assessments of brain amyloid reduction and five-year clinical status of people living with early Alzheimer’s disease (AD) from the lecanemab Phase 2b 201 and the open-label extension (OLE) studies.
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in people with early AD and confirmed amyloid pathology.
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early Alzheimer’s disease and confirmed amyloid pathology.
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in people with early AD and confirmed amyloid pathology.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, “Biogen”) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer’s disease (AD).
Stockholm, 23 June 2021 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer’s disease.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, “Biogen”) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer’s disease (AD).
The manuscript concluded that the pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the Phase 3 clinical trial Clarity AD aims to confirm.
The manuscript concluded that the pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the Phase 3 clinical trial Clarity AD aims to confirm.
Preliminary results presented from the ongoing open-label extension of the Phase 2b study in early Alzheimer’s disease continue to support the effect of lecanemab on brain amyloid levels.
The preliminary results show, among other things, a continuous decrease in amyloid levels in the brain measured at three, six and twelve months with BAN2401 treatment in those patients who had previously received placebo.
The 10 mg/kg monthly and 10 mg/kg bi-weekly doses were determined to have greater efficacy, and as a result, the proportion of patients allocated to those treatment arms was greater.
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced on July 6 the positive topline results from the clinical Phase 2b study with BAN2401 in 856 patients with early Alzheimer’s disease.
Eisai and Biogen announced on July 6 that Study 201 achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer’s Disease Composite Score (ADCOMS) and on reduction of amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography).
Treatment of Early AD subjects with BAN2401, an Anti-Aβ Protofibril Monoclonal Antibody, Significantly Clears Amyloid Plaque and Reduces Clinical Decline
The study achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer’s Disease Composite Score (ADCOMS) and on reduction of amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography).
The full 18 month analysis of the 856 patient BAN2401 Phase 2b clinical study in early Alzheimer’s disease demonstrated statistically significant and dose-dependent slowing in clinical decline and reduction of amyloid beta accumulated in the brain.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (NASDAQ:BIIB) (Headquarters: Cambridge, Massachusetts, United States, CEO: Michel Vounatsos, “Biogen”) announced positive topline results from the Phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer's disease.
BAN2401, an anti-amyloid beta protofibril antibody, did not meet the criteria for success based on a Bayesian analysis at 12 months as the primary endpoint in an 856-patient Phase Ⅱ clinical study (Study 201).
Every value below carries the sentence it was read from.
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Field
Value
Cited text
Known as
Lecanemab
“Lecanemab Single Dose Ascending Single intravenous infusions at sequentially ascending doses on Day 1 (dose levels: 0.1, 0.3, 1, 3, 10, and 15 mg/kg)” NCT01230853 ↗15
“efficacy and safety of lecanemab (10 mg/kg administered every two weeks)” NCT07034222 ↗
“Lecanemab (BAN2401), an IgG1 monoclonal antibody” PMID 33865446 ↗Apr 2021
Route
Intravenous
“Lecanemab Single Dose Ascending Single intravenous infusions at sequentially ascending doses on Day 1 (dose levels: 0.1, 0.3, 1, 3, 10, and 15 mg/kg)” NCT01230853 ↗