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# Octapharma’s Fibryga OK’s for Expanded Use
- URL: https://www.fdaweb.com/octapharmas-fibryga-oks-for-expanded-use/
- Published: 2024-08-02T12:00:00.000Z
- Updated: 2026-09-14T14:37:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157496

FDA has approved an Octapharma supplemental NDA for the expanded approval of Fibryga (fibrinogen lyophilized powder for reconstitution) for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD). The company says AFD often results from severe bleeding and can weaken blood clot formation, increasing hemorrhage risk in patients.

The expanded approval was based on the FIBRES (FIBrinogen REplenishment in Surgery) study that demonstrated that fibrinogen concentrate was non-inferior to cryoprecipitate (standard of care) and may be used instead of cryoprecipitate for treating bleeding related to AFD, Octapharma says.

Finryga was originally approved in 2017 for acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency.