Bayer Receives Positive CHMP Opinion for Its Hemophilia a Treatment

Bayer announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended BAY94-9027 for the marketing authorization for treatment and prophylaxis of bleeding in previously treated patients 12 years of age or older with hemophilia 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(R).

“For physicians treating hemophilia A patients with a range of individualized needs, it is important to have the opportunity to offer a treatment which delivers sustained levels of Factor VIII in the blood and thus providing good bleed protection,” said Prof. Dr. Oldenburg, Director of the Hemophilia Centre at the University Clinic in Bonn, Germany. “BAY94-9027 was engineered to have an extended half-life by harnessing proven PEG-technology, which could extend the blood’s ability to coagulate for longer.”

“BAY94-9027 is a uniquely designed recombinant Factor VIII molecule that has demonstrated efficacy and a good safety profile with the potential for reduced injection frequency in adults and adolescents,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “After the approval of BAY94-9027 in the U.S., the positive CHMP recommendation is an important step forward for people with hemophilia A in the European Union. Bayer has also submitted marketing authorization applications for BAY94-9027 in other countries.”

https://www.marketscreener.com/BAYER-436063/news/Bayer-Receives-Positive-CHMP-Opinion-for-Its-Hemophilia-a-Treatment-BAY94-9027-27302161/