Drugs / Aducanumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | Alzheimer disease | 2020-12-09 | “Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab” biogen.com ↗ |
| Filed | EU (EMA) | — | Alzheimer disease | 2020-10-30 | “the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab” eisai.com ↗ “has disclosed its submission of the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the review of aducanumab” eisai.com ↗ |
| Filed | US (FDA) | — | Alzheimer disease | 2020-07-08 | “today announced that Biogen has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of aducanumab” biogen.com ↗ “Biogen submitted the aducanumab BLA to the FDA in July 2020.” biogen.com ↗ |
| Filed | Other | — | Alzheimer disease | — | “In the first quarter of 2021 Biogen submitted a MAA to Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil for aducanumab an investigational treatment for Alzheimer’s disease.” eisai.com ↗ “Biogen also submitted MAAs for aducanumab to Health Canada, the Therapeutic Goods Agency in Australia, and Swissmedic in Switzerland” eisai.com ↗ “Biogen also submitted MAAs for aducanumab to Health Canada, the Therapeutic Goods Agency in Australia” eisai.com ↗ “Biogen also submitted MAAs for aducanumab to Health Canada” eisai.com ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT05216887 | Feb → Jul 2022 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT04924140 | Jun → Oct 2021 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT02782975 | May → Nov 2016 | Alzheimer disease | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT02434718 | Jun 2015 → Dec 2016 | Alzheimer disease | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01677572 | Oct 2012 → Jul 2019 | Alzheimer disease | Biogen | Terminated | No outcome recorded |
| Phase 1 | NCT01397539 | Jun 2011 → Aug 2013 | Alzheimer disease | Biogen | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03639987 | Dec 2018 → Jul 2019 | Alzheimer disease | Biogen | Terminated | No outcome recorded |
| Phase 34 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT05310071 | Jun 2022 → Aug 2024 | Alzheimer disease | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT04241068 | Mar 2020 → Jul 2024 | Alzheimer disease | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT02484547 | Sep 2015 → Aug 2019 | Alzheimer disease | Biogen | Terminated | Met primary |
| Phase 3 | NCT02477800 | Aug 2015 → Aug 2019 | Alzheimer disease | Biogen | Terminated | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 0 | NCT05469009 Background | Jul 2022 → Jul 2029 expected | Alzheimer disease type 1, cognitive impairment with or without cerebellar ataxia | Ali Rezai | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05108922 Comparator | Nov 2021 → Sep 2022 | Alzheimer disease | Eli Lilly and Company | Completed | Met primary |
News releases announcing trial results or a regulatory action · 49
| Date | Issuer | Release |
|---|---|---|
| 2022-04-29 | Biogen | Regulatory Biogen Statement Regarding Updated ADUHELM® (aducanumab-avwa) Prescribing Information in US biogen.com ↗
The US Food and Drug Administration (FDA) has approved an updated full Prescribing Information for ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use, which includes further guidance on how to monitor patients and provides additional safety information. |
| 2022-04-22 | Biogen | Regulatory Update on Regulatory Submission for Aducanumab in the European Union biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) has notified the European Medicines Agency (EMA) of its decision to withdraw its Marketing Authorization Application (MAA) for aducanumab for the treatment of the early stages of Alzheimer’s disease. |
| 2022-04-08 | Eisai Inc. | Regulatory EISAI STATEMENT ON THE CENTERS FOR MEDICARE AND MEDICAID SERVICES’ NATIONAL COVERAGE DETERMINATION WITH COVERAGE WITH EVIDENCE DEVELOPMENT FOR MONOCLONAL ANTIBODIES DIRECTED AGAINST AMYLOID FOR THE TREATMENT OF ALZHEIMER’S DISEASE eisai.com ↗
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. |
| 2022-04-07 | Biogen | Regulatory Biogen’s Statement on the Final National Coverage Determination for Amyloid-Beta Targeting Therapies for the Treatment of Alzheimer’s Disease biogen.com ↗
This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. |
| 2022-03-16 | Biogen | Results Long-Term Phase 3 Data Show ADUHELM® Continues to Reduce Underlying Pathologies of Alzheimer’s Disease in Patients Treated for More Than Two Years biogen.com ↗
Data from the long-term extension study showed that ADUHELM significantly reduced amyloid beta plaque levels out to Week 132. |
| 2022-03-16 | Biogen | Results Biogen Announces Peer-Reviewed Publication of ADUHELM® Phase 3 EMERGE and ENGAGE Data in The Journal of Prevention of Alzheimer’s Disease biogen.com ↗
The publication includes results from the primary, secondary and tertiary endpoints in the trials, as well as safety data and biomarker sub-studies. |
| 2022-01-11 | Biogen | Regulatory Biogen’s Statement on the Draft National Coverage Determination (NCD) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease biogen.com ↗
It is also particularly concerning that this draft implies that some Medicare beneficiaries will receive a placebo instead of a treatment they are seeking. |
| 2021-12-22 | Biogen | Regulatory Japan’s First Committee on New Drugs of The Pharmaceutical Affairs and Food Sanitation Council Seeks Additional Data; Aducanumab Remains under Review biogen.com ↗
The NDC is seeking additional data to be submitted as part of this process. |
| 2021-12-17 | Eisai Inc. | Regulatory Update on Regulatory Submission for Aducanumab in the European Union Biogen to seek re-examination following CHMP negative opinion for aducanumab eisai.com ↗
Biogen will seek a re-examination of the opinion by the CHMP. |
| 2021-12-17 | Biogen | Regulatory Update on Regulatory Submission for Aducanumab in the European Union biogen.com ↗
Biogen will seek a re-examination of the opinion by the CHMP. |
| 2021-11-22 | Biogen | Results Statement on JAMA Neurology Publication about Amyloid-Related Imaging Abnormalities in Two Phase 3 Studies Evaluating Aducanumab in Early Alzheimer’s Disease biogen.com ↗
Today, Biogen and Eisai announced that the Journal of the American Medical Association (JAMA) Neurology published a peer-reviewed paper about findings around amyloid-related imaging abnormalities (ARIA) in the Phase 3 trials of ADUHELM (aducanumab-avwa). |
| 2021-11-17 | Eisai Inc. | Regulatory Update on Regulatory Review of Aducanumab in the European Union eisai.com ↗
Following an oral explanation held at the November meeting of the CHMP, Biogen received a negative trend vote on the aducanumab Marketing Authorization Application. |
| 2021-11-17 | Biogen | Regulatory Update on Regulatory Review of Aducanumab in the European Union biogen.com ↗
Following an oral explanation held at the November meeting of the CHMP, Biogen received a negative trend vote on the aducanumab Marketing Authorization Application. |
| 2021-11-11 | Biogen | Results New Phase 3 Data Show Positive Correlation Between ADUHELM™ Treatment Effect on Biomarkers and Reduction in Clinical Decline in Alzheimer’s Disease biogen.com ↗ |
| 2021-07-27 | Eisai Inc. | Results Biogen and Eisai Announce ADUHELM™ (aducanumab-avwa) Data Presentations at Alzheimer’s Association International Conference 2021 eisai.com ↗
Item-level analysis from EMERGE trial shows consistency in slowing decline across cognitive, functional and behavioral measures in early Alzheimer’s disease |
| 2021-07-26 | Biogen | Results Biogen and Eisai Announce ADUHELM™ (aducanumab-avwa) Data Presentations at Alzheimer’s Association International Conference 2021 biogen.com ↗
Item-level analysis from EMERGE trial shows consistency in slowing decline across cognitive, functional and behavioral measures in early Alzheimer’s disease |
| 2021-07-08 | Biogen | Regulatory FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials biogen.com ↗
Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced the U.S. Food and Drug Administration (FDA) has approved an updated label for ADUHELM™ (aducanumab-avwa) injection 100 mg/mL solution. |
| 2021-06-07 | Biogen | Regulatory A Letter from Biogen’s CEO on ADUHELM biogen.com ↗
The approval of ADUHELM represents a crucial inflection point in our collective battle against Alzheimer’s disease. |
| 2021-06-07 | Biogen | Regulatory FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease biogen.com ↗
The accelerated approval has been granted based on data from clinical trials demonstrating the effect of ADUHELM on reducing amyloid beta plaques, a biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline. |
| 2021-04-23 | Eisai Inc. | Regulatory NOTICE REGARDING BIOGEN’S DISCLOSURE ABOUT THE SUBMISSION OF MARKETING AUTHORIZATION APPLICATIONS IN BRAZIL, CANADA, AUSTRALIA, AND SWITZERLAND FOR ADUCANUMAB FOR ALZHEIMER’S DISEASE eisai.com ↗
In the first quarter of 2021 Biogen submitted a MAA to Agência Nacional de Vigilância Sanitária (ANVISA) in Brazil for aducanumab an investigational treatment for Alzheimer’s disease. |
| 2021-01-29 | Biogen | Regulatory Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab biogen.com ↗
Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. |
| 2020-12-10 | Eisai Inc. | Regulatory BIOGEN FILES NEW DRUG APPLICATION FOR ADUCANUMAB IN JAPAN If approved, aducanumab would become the first treatment to meaningfully change the course of Alzheimer’s disease Aducanumab is now under regulatory review in Japan, Europe and the United States eisai.com ↗
Today, Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. |
| 2020-12-09 | Biogen | Regulatory Biogen Files New Drug Application for Aducanumab in Japan biogen.com ↗
Today, Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. |
| 2020-11-07 | Eisai Inc. | Regulatory Update on FDA Advisory Committee’s meeting on aducanumab in Alzheimer’s disease eisai.com ↗
The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question “Does Study 103 (PRIME) provides supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?” |
| 2020-11-06 | Biogen | Regulatory Update on FDA Advisory Committee’s Meeting on Aducanumab in Alzheimer’s Disease biogen.com ↗
Today, the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted 1 yes, 8 no and 2 uncertain |
| 2020-10-30 | Eisai Inc. | Regulatory European Medicines Agency Accepts Biogen’s Aducanumab Marketing Authorization Application for Alzheimer's Disease If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease eisai.com ↗ |
| 2020-10-30 | Biogen | Regulatory European Medicines Agency Accepts Biogen’s Aducanumab Marketing Authorization Application for Alzheimer's Disease biogen.com ↗
Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. |
| 2020-10-21 | Eisai Inc. | Regulatory NOTICE REGARDING BIOGEN’S DISCLOSURE ABOUT THE SUBMISSION OF MARKETING AUTHORIZATION APPLICATION TO EUROPEAN MEDICINES AGENCY FOR ADUCANUMAB FOR ALZHEIMER’S DISEASE eisai.com ↗
This MAA is subject to validation of whether the EMA accepts the application for review, which Biogen plans to announce when notified. |
| 2020-08-07 | Biogen | Regulatory FDA Accepts Biogen’s Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review biogen.com ↗
Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. |
| 2020-07-08 | Eisai Inc. | Regulatory Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease If approved, aducanumab would be the first treatment with the potential to meaningfully change the course of Alzheimer’s disease eisai.com ↗
today announced that Biogen has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the approval of aducanumab, an investigational treatment for Alzheimer’s disease. |
| 2020-07-08 | Biogen | Regulatory Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease biogen.com ↗ |
| 2019-10-22 | Eisai Inc. | Results Biogen Plans Regulatory Filing for Aducanumab in Alzheimer’s Disease Based on New Analysis of Larger Dataset from Phase 3 Studies eisai.com ↗
New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified primary and secondary endpoints |
| 2019-10-22 | Biogen | Results Biogen Plans Regulatory Filing for Aducanumab in Alzheimer’s Disease Based on New Analysis of Larger Dataset from Phase 3 Studies biogen.com ↗
New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified primary and secondary endpoints |
| 2019-03-21 | Eisai Inc. | Results Biogen and Eisai to Discontinue Phase 3 ENGAGE and EMERGE Trials of aducanumab in Alzheimer’s Disease Independent data monitoring committee advises aducanumab unlikely to meet primary endpoints, leading to decision to discontinue the trials eisai.com ↗
The decision to stop the trials is based on results of a futility analysis conducted by an independent data monitoring committee, which indicated the trials were unlikely to meet their primary endpoint upon completion. |
| 2019-03-21 | Biogen | Results Biogen and Eisai to Discontinue Phase 3 ENGAGE and EMERGE Trials of aducanumab in Alzheimer’s Disease biogen.com ↗ |
| 2018-10-29 | Eisai Inc. | Results Biogen and Eisai Announce Presentation of Detailed Analyses from the Phase 1b Long-Term Extension Study of Aducanumab at Clinical Trials on Alzheimer’s Disease (CTAD) Three- and four-year data continued to show reduction in amyloid plaque and to suggest a slowing of the rate of clinical decline in patients eisai.com ↗
Data from both analyses showed a reduction in amyloid plaque levels in a dose- and time-dependent manner, as measured by positron emission tomography (PET). |
| 2018-10-26 | Biogen | Results Biogen and Eisai Announce Presentation of Detailed Analyses from the Phase 1b Long-Term Extension Study of Aducanumab at Clinical Trials on Alzheimer’s Disease (CTAD) biogen.com ↗
Data from both analyses showed a reduction in amyloid plaque levels in a dose- and time-dependent manner, as measured by positron emission tomography (PET). |
| 2018-08-29 | Eisai Inc. | Results Biogen and Eisai Report Data from Long-Term Extension Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab Data Includes Additional Analyses of Long-Term Extension Phase 1b Study With Titration Cohort at 36 Months and Fixed-Dose Cohorts at 48 Months eisai.com ↗
The updated analyses include data from the placebo-controlled period and LTE for patients treated with aducanumab up to 36 months in the titration cohort and up to 48 months in the fixed-dose cohorts. |
| 2018-08-28 | Biogen | Results Biogen and Eisai Report Data from Long-Term Extension Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab biogen.com ↗
The results are generally consistent with previous interim analyses, and there were no changes to the risk-benefit profile of aducanumab. |
| 2018-03-15 | Biogen | Results Biogen to Present at the 2018 Advances in Alzheimer’s and Parkinson’s Therapies (AAT-AD/PD) Focus Meeting biogen.com ↗
At 54 weeks, the treatment group receiving the highest dose of aducanumab (10 mg/kg) experienced a 69% reduction from baseline in amyloid plaque as observed on the Centiloid Conversion scale (P<0.001 versus placebo). |
| 2017-11-06 | Eisai Inc. | Results NEW DATA FROM LONG-TERM EXTENSION OF PHASE 1b STUDY OF INVESTIGATIONAL ALZHEIMER'S DISEASE TREATMENT ADUCANUMAB PRESENTED AT 10TH CLINICAL TRIALS ON ALZHEIMER'S DISEASE eisai.com ↗
Two-year data from Phase 1b study suggest a continued benefit on amyloid plaque reduction and the rate of clinical decline in the titration regimen group, which received a gradually increased aducanumab dose |
| 2017-11-02 | Biogen | Results Biogen Presents New Data from Long-Term Extension of Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab biogen.com ↗
Two-year data from Phase 1b study suggest a continued benefit on amyloid plaque reduction and the rate of clinical decline in the titration regimen group, which received a gradually increased aducanumab dose |
| 2017-08-28 | Biogen | Results Biogen Reports New Data from Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab biogen.com ↗
Biogen (NASDAQ: BIIB) today announced results from a recently conducted analysis of the long-term extension (LTE) of its ongoing Phase 1b study of aducanumab, the company’s investigational treatment for early Alzheimer’s disease. |
| 2016-12-08 | Biogen | Results Biogen Presents Data from Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab at 2016 Clinical Trials on Alzheimer’s Disease Meeting biogen.com ↗
Data presentations include interim results from the titration cohort of the placebo-controlled period of the Phase 1b study as well as data from the first year of the long-term extension (LTE). |
| 2016-09-01 | Biogen | Regulatory Biogen’s Investigational Alzheimer’s Disease Treatment Aducanumab Granted FDA Fast Track Designation biogen.com ↗
Today Biogen (NASDAQ: BIIB) announced that aducanumab, its investigational treatment for early Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). |
| 2016-08-31 | Biogen | Results Nature Publishes Results from Pre-Clinical Research and Phase 1b Study of Biogen’s Investigational Alzheimer’s Disease Treatment Aducanumab biogen.com ↗
The pre-clinical animal model and Phase 1b placebo-controlled study in prodromal and mild AD patients (n=165), both demonstrate that aducanumab reduced amyloid-beta in the brain and the reduction was dose-dependent. |
| 2016-06-01 | Biogen | Regulatory Biogen’s Investigational Alzheimer’s Disease Treatment Aducanumab Accepted into European Medicines Agency’s PRIME Program biogen.com ↗
Today Biogen (NASDAQ:BIIB) announced that aducanumab, its investigational treatment for early Alzheimer’s disease (AD), was accepted into the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) program. |
| 2015-07-22 | Biogen | Results Biogen Presents New Data from Phase 1B Study of Investigational Alzheimer’s Disease Treatment Aducanumab (BIIB037) at Alzheimer’s Association International Conference® 2015 biogen.com ↗
Consistent with previously reported results, the 54-week data from the 6 mg/kg arm demonstrated a statistically significant reduction of beta amyloid in the brain. |
| 2015-03-20 | Biogen | Results Biogen Idec Presents Positive Interim Results from Phase 1B Study of Investigational Alzheimer’s Disease Treatment Aducanumab (BIIB037) at 2015 AD/PD™ Conference biogen.com ↗
In exploratory analyses, a dose-dependent, statistically significant effect of slowing clinical decline was observed on the Mini Mental State Examination (MMSE) and Clinical Dementia Rating (CDR) scales. |
All press releases naming this drug 80 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Aducanumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01677572 ↗ |
| Known as | aducanumab-avwa | “A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic...” NCT05108922 ↗ |
| Known as | Aduhelm | ChEMBL registry synonym — accepted as the source's own label CHEMBL3039540 ↗ |
| Known as | BIIB037 | “Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103,...” NCT04241068 ↗6“Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease” NCT01677572 ↗ “Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease” NCT02434718 ↗ “221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease” NCT02484547 ↗ “221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease” NCT02477800 ↗ “Aducanumab (BIIB037)” NCT03639987 ↗ |
| Modality | Monoclonal antibody | “BIIB037 is a fully human immunoglobulin gamma 1 (IgG1) monoclonal antibody” NCT01397539 ↗ |
| Route | Intravenous | “single intravenous (IV) infusions” NCT01397539 ↗ |
| Target | APP | “Amyloid-beta A4 protein binding agent” CHEMBL3039540 ↗ |