Drugs / EFTRENONACOG ALFA
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hemophilia B leyden 3 milestones | |||||
| Filed | EU (EMA) | Alprolix | hemophilia B leyden | 2015-06-04 | “Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that partner Biogen has submitted a Marketing Authorisation Application (MAA) for Alprolix (rFIXFc) to the European...” sobi.com ↗ “On 26 June 2015 Sobi and Biogen announced that the European Medicines Agency (EMA) had validated the Marketing Authorisation Application (MAA) for Alprolix.” sobi.com ↗ “Sobi's collaboration partner Biogen submitted the Marketing Authorisation Application for Alprolix® (rFIXFc) in Europe” sobi.com ↗ |
| Filed | Other | ALPROLIX | hemophilia B leyden | — | “Marketing Applications for ELOCTATE and ALPROLIX have been submitted in Australia for the treatment of hemophilia A and B, respectively.” biogen.com ↗ “Marketing Applications for ALPROLIX have been submitted in Canada and Australia for the treatment of hemophilia B.” biogen.com ↗ |
| Filed | US (FDA) | ALPROLIX | hemophilia B leyden | — | “ALPROLIX are currently under review with the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia A and B, respectively.” biogen.com ↗ “candidate ALPROLIX is currently under review with the U.S. Food and Drug Administration (FDA)” biogen.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Alprolix | — | 2016-05-12 | europa.eu ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03272568 | Feb 2018 → Dec 2019 | hemophilia, menstrual disorder | Emory University | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT00716716 | Apr 2008 → Oct 2009 | hemophilia B | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT02234310 | Nov 2014 → Aug 2019 | hemophilia B | Bioverativ, a Sanofi company | Completed | No outcome recorded |
| Phase 3 | NCT01440946 | Jun 2012 → Nov 2014 | hemophilia B | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01425723 | Dec 2011 → Oct 2017 | severe hemophilia B | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01027364 | Dec 2009 → Jul 2012 | severe hemophilia B | Bioverativ Therapeutics Inc. | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT03075670 Comparator | Mar → Dec 2017 | congenital hematological disorder, hemophilia B | Novo Nordisk A/S | Completed | Met primary |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2021-11-04 | Sobi, Inc. | Results Sobi to present new data at the ASH 2021 Annual Meeting sobi.com ↗
rFIXFc Reduces the Frequency and Delays Time to First Spontaneous Bleed Event in Previously Untreated Patients with Hemophilia B: A Post Hoc Analysis of the PUPs B-LONG Trial. |
| 2021-11-04 | Sanofi | Results New data in blood cancers, hemophilia, and other hematological disorders to be presented at ASH 2021 sanofi.com ↗ |
| 2020-10-29 | Sobi, Inc. | Regulatory Favourable paediatric data results in Alprolix ® product information update sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announced that the European Commission has approved an update to the Alprolix® (eftrenonacog alfa) Summary of Product Characteristics (SmPC) to include additional information regarding use among previously untreated patients (PUPs) with haemophilia B. |
| 2020-07-13 | Sobi, Inc. | Results Data presented at ISTH2020 strengthens evidence for both Elocta ® and Alprolix ® in previously untreated patients with haemophilia sobi.com ↗
Alprolix was well tolerated and effective for both prophylaxis and treatment of bleeding episodes. |
| 2019-07-09 | Sobi, Inc. | Results Switching to extended half-life prophylaxis impacted clinical outcomes and improved quality of life for people with haemophilia A or B sobi.com ↗
Clinical study data on switching haemophilia A and B patients from on-demand treatment to extended half-life (EHL) prophylaxis showed a positive impact on clinical outcomes, with improvements in quality of life (QoL) and reduced annual bleeding rates (ABR). |
| 2019-05-10 | Sobi, Inc. | Results Individualised extended half-life factor replacement therapy controls haemostasis in orthopaedic surgery sobi.com ↗
Most major procedures required one injection to maintain haemostasis during surgery, and all haemostatic responses were assessed as excellent or good by the investigator/surgeon. |
| 2018-12-01 | Sobi, Inc. | Results At ASH, extended half-life therapies Elocta® and Alprolix® demonstrate proven efficacy and well-characterised safety over four years sobi.com ↗
ASPIRE and B-YOND extension studies show no inhibitor development and consistently low annualised bleeding rates in study participants over four years with Elocta and Alprolix, respectively. |
| 2016-05-13 | Sobi, Inc. | Regulatory Alprolix® (rFIXFc) approved in the EU for the treatment of haemophilia B sobi.com ↗ |
| 2016-05-13 | Biogen | Regulatory Alprolix® (rFIXFc) Approved in the EU for the Treatment of Haemophilia B biogen.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) and Biogen (NASDAQ:BIIB) today announced that the European Commission (EC) has approved Alprolix ® (rFIXFc), their extended half-life therapy, for the treatment of haemophilia B in all 28 European Union (EU) member states and maintained its orphan designation. |
| 2016-04-11 | Sobi, Inc. | Regulatory Sobi and Biogen receive positive opinion from CHMP for Alprolix® (rFIXFc) for the treatment of haemophilia B sobi.com ↗ |
| 2016-02-26 | Sobi, Inc. | Regulatory Sobi and Biogen receive positive opinion from CHMP for Alprolix® (rFIXFc) for the treatment of haemophilia B sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) (STO: SOBI) and Biogen (NASDAQ: BIIB) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending that marketing authorisation be granted for Alprolix® (rFIXFc), a recombinant factor IX Fc fusion protein therapy for the treatment of haemophilia B. |
| 2016-02-26 | Biogen | Regulatory Sobi and Biogen Receive Positive Opinion from CHMP for Alprolix® (rFIXFc) for the Treatment of Hemophilia B biogen.com ↗ |
| 2015-06-26 | Sobi, Inc. | Regulatory Biogen and Sobi announce European Medicines Agency validates Alprolix® (rFIXFc) marketing authorisation application sobi.com ↗ |
| 2015-06-26 | Biogen | Regulatory Biogen and Sobi Announce European Medicines Agency Validates ALPROLIX® (rFIXFc) Marketing Authorization Application biogen.com ↗
Biogen (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) of ALPROLIX ® (rFIXFc), a recombinant factor IX Fc fusion protein product candidate for the treatment of hemophilia B. |
| 2015-06-04 | Sobi, Inc. | Regulatory Sobi's partner Biogen submits marketing authorisation application for Alprolix® (rFIXFc) in Europe sobi.com ↗
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that partner Biogen has submitted a Marketing Authorisation Application (MAA) for Alprolix (rFIXFc) to the European Medicines Agency (EMA). |
| 2014-03-21 | Sobi, Inc. | Regulatory Health Canada approves Alprolix(TM) sobi.com ↗
Alprolix is the first approved long-acting haemophilia B therapy and is indicated to prevent or reduce the frequency of bleeding episodes with prophylactic injections scheduled once weekly or once every 10-14 days. |
| 2013-12-09 | Sobi, Inc. | Results Swedish Orphan Biovitrum AB (publ): New phase 3 data confirm long-lasting characteristics of rFIXFc and rFVIIIFc across multiple haemophilia populations sobi.com ↗
These interim data are the first to demonstrate that rFIXFc and rFVIIIFc have consistently prolonged half- lives (a measure of the time therapy circulates in the bloodstream) in children, compared to study participants' prior therapies. |
| 2013-12-03 | Biogen | Results Biogen Idec Demonstrates Commitment to Advancing Hemophilia Research and Care at Annual ASH Meeting biogen.com ↗
New, Interim Phase 3 Data Highlight Prolonged Half-Life of ELOCTATE™ and ALPROLIX™ in Young Children |
| 2013-07-02 | Sobi, Inc. | Results Biogen Idec and Sobi Present New Data from the Phase 3 Study of their Long-Lasting Haemophilia Factor Candidate ALPROLIX (TM) sobi.com ↗
Results from an analysis of the phase 3 B-LONG study showed that ALPROLIX consistently controlled bleeding during and after 14 major surgeries in 12 patients with haemophilia B. |
| 2013-07-02 | Biogen | Results Biogen Idec and Sobi Present New Data from the Phase 3 Study of Their Long-Lasting Hemophilia Factor Candidate ALPROLIX™ biogen.com ↗
Results from an analysis of the phase 3 B-LONG study showed that ALPROLIX consistently controlled bleeding during and after 14 major surgeries in 12 patients with hemophilia B. |
| 2013-06-24 | Biogen | Results Biogen Idec Showcases Commitment to Advancing Hemophilia Treatment and Care at ISTH Congress biogen.com ↗
New Phase 3 Data Support Potential Efficacy, Safety and Pharmacokinetics of Long-Lasting Factor Product Candidates |
All press releases naming this drug 33 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EFTRENONACOG ALFA | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594598 ↗ |
| Known as | Alprolix | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03272568 ↗ |
| Known as | BIIB-029 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594598 ↗ |
| Known as | Recombinant factor IX-Fc fusion protein | “Recombinant factor IX-Fc fusion protein (rFIXFc) demonstrates safety and prolonged activity in a phase 1/2a study in hemophilia B patients.” PMID 22110246 ↗ Nov 2011 |
| Known as | rFIXFc | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01440946 ↗ |
| Action | Restore | “Subjects will get FIX activity corrected from the baseline level to 100-150% with Alprolix” NCT03272568 ↗ |
| Modality | Protein / enzyme biologic | “rFIXFc is a recombinant fusion protein composed of FIX and the Fc domain of human IgG(1), to extend circulating time.” PMID 22110246 ↗ Nov 2011 |
| Route | Intravenous | “A Phase I/IIa Safety and Pharmacokinetic Study of Intravenous FIXFc in Previously Treated Hemophilia B Patients” NCT00716716 ↗ |
| Target | F9 | “Coagulation factor IX exogenous protein” CHEMBL4594598 ↗ |