Posted by Michael Wonder on 24 Sep 2018
Bayer receives positive CHMP opinion for its haemophilia A treatment BAY94-9027
21 September 2018 - The safety and efficacy profile of BAY94-9027 has been demonstrated in more than five years of clinical studies.
Bayer announced today that the CHMP of the European Medicines Agency has recommended BAY94-9027 for the marketing authorisation for treatment and prophylaxis of bleeding in previously treated patients 12 years of age or older with haemophilia A.
The CHMP recommendation is based on results from the Phase 2/3 PROTECT VIII trial. BAY94-9027 recently received FDA approval in the U.S. where it is marketed under the brand name Jivi.
