5 November 2019 - 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. 

The approval extends the market authorisation for fibryga, which is already approved for use in patients with congenital fibrinogen deficiency. The addition represents a major milestone for bleeding management in critical care settings.

The approval of fibryga for use in AFD is based on results of the FORMA-05 clinical study. This phase II, prospective, randomised, single-blind, controlled, non-inferiority study compared the efficacy of fibryga with that of standard of care (cryoprecipitate) during cytoreductive surgery to treat the rare cancer Pseudomyxoma peritonei. This major and complex surgical procedure is associated with extensive blood loss and patients are at high risk of developing AFD.

Read Octapharma press release