Posted by Michael Wonder on 12 Dec 2023
FDA and EMA accept marstacimab regulatory submissions for the treatment of haemophilia A and B
11 December 2023 - Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology Annual Meeting.
Pfizer today announced that the US FDA has accepted the company’s biologics license application for its anti-tissue factor pathway inhibitor candidate marstacimab for individuals living with haemophilia A or haemophilia B without inhibitors to factor VIII (FVIII) or Factor IX (FIX).
The European marketing authorisation application for marstacimab also passed validation and is currently under review by the EMA.
