Stopped: FORMA-07 was initiated as a requirement imposed by the U.S. FDA as part of Octapharma's regulatory obligations. After approving Fibryga for treatment of acquired fibrinogen deficiency in 2024, FDA has agreed that the study may now be discontinued.
Open-label, Uncontrolled, Multicenter Observational Study on the Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency
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The incidence of thromboembolic adverse drug reactions (ADRs)
Timeframe: Day 0-28