Drugs / Fibryga
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT04534751 | Apr 2021 → Dec 2023 | blood coagulation disease | University Health Network, Toronto | Unknown | Missed primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | Octapharma | Results Fewer Blood Components Transfused with fibryga® Than Cryoprecipitate, Secondary Analysis of Prespecified FIBRES Subgroups Reports octapharma.com ↗ |
| 2024-08-09 | Octapharma | Regulatory FDA approves fibryga® for acquired fibrinogen deficiency, potentially ushering in a new standard of care octapharma.com ↗
Octapharma USA, Inc. has announced the expanded approval of fibryga ® , Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD) by the U.S. Food and Drug Administration (FDA). |
| 2021-03-30 | Octapharma | Regulatory FDA approvals strengthen Octapharma USA pediatric critical care product portfolio octapharma.com ↗
The supplement approvals resulted in new product labeling for Octaplas ™, Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion, and fibryga® , Fibrinogen (Human) Lyophilized Powder for Reconstitution. |
| 2020-08-14 | Octapharma | Regulatory Octapharma’s Fibryga® receives Health Canada approval to treat acquired fibrinogen deficiency (AFD) in surgical settings octapharma.com ↗
Octapharma Canada announces that Fibryga® (Human Fibrinogen Concentrate, HFC) has received Health Canada approval for use in treatment of acquired fibrinogen deficiency (AFD), in the course of surgical interventions. |
| 2020-01-21 | Octapharma | Results Positive results for fibryga® in the treatment of bleeding and surgical prophylaxis in patients with congenital fibrinogen deficiency (FORMA-02) published in the Journal of Thrombosis and Haemostasis octapharma.com ↗
The final results of the Phase 3 clinical trial investigating fibryga® for the treatment of bleeding and surgical prophylaxis in patients with congenital fibrinogen deficiency (FORMA-02) has been published in the Journal of Thrombosis and Haemostasis (JTH). |
| 2019-11-05 | Octapharma | Regulatory Octapharma’s fibryga® receives European label extension to treat acquired fibrinogen deficiency (AFD) octapharma.com ↗
Octapharma announced today that the human fibrinogen concentrate fibryga ® has received approval for use in treatment of acquired fibrinogen deficiency (AFD) in 15 European countries. |
| 2019-10-31 | Octapharma | Results Octapharma announces publication of data on fibryga® for the treatment of acquired fibrinogen deficiency in patients undergoing cardiac surgery octapharma.com ↗
The data met the study’s prespecified noninferiority criterion and led to early termination of the trial. |
All press releases naming this drug 7 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fibryga | “Intervention group: 4 g Fibryga and 2000 IU Octaplex will be released as part of the first and second MHP packs.” NCT04534751 ↗ |