FDA Approves Additional Indication for Fibryga
- By BSTQ Staff
Octapharma USA’s Fibryga (fibrinogen [human] lyophilized powder for reconstitution) has received U.S. Food and Drug Administration (FDA) approval for an additional indication: fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD). As the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate option with this approval, Fibryga represents a rapid and more precise option for severe bleeding scenarios than the current standard of care (cryoprecipitate).
The expanded FDA approval of Fibryga was based on the FIBRES [FIBrinogen REplenishment in Surgery] study published in JAMA, which was a head-to-head, multicenter, randomized clinical trial of 735 patients, demonstrating that fibrinogen concentrate was noninferior to cryoprecipitate and may be used instead of cryoprecipitate for the treatment of bleeding related to AFD. Fibryga has already received regulatory approval for the treatment of AFD in both the European Union in 2019 and Canada in 2020.
“In the surgical theater, time matters. And confidence matters. This expanded FDA approval of Fibryga represents a major step forward in our commitment to redefining the standard of care for patients experiencing major bleeding. It provides an important option for providers who must act urgently,” said Flemming Nielsen, president of Octapharma USA. “We are proud to be the first to offer this therapeutic advancement — and a new standard of care — to hospitals, anesthesiologists, surgeons, OB/GYNs and patients across the United States.”
This approval marks the third FDA approval received to date for Fibryga. In 2017, FDA granted an approval for acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. A second was received in 2020 for pediatric patients under 12 years for treatment of acute bleeding episodes in congenital fibrinogen deficiency.
