
FDA Accepts BLA For Bayer's Proposed Hemophilia A Treatment
Bayer has announced the FDA’s acceptance of its Biologics License Application (BLA) for BAY94-9027 for the treatment of hemophilia A in adults and adolescents aged 12 years or older.
Bayer has
Hemophilia A is a genetic bleeding
Submission of the BLA is based on results from the
A total of 134 patients were treated in the study. After a 10-week run-in period of twice-weekly dosing, patients who had 1 breakthrough bleed or less during the 10-week period were randomized to receive BAY94-9027 every 5 days or every 7 days for 26 weeks. Patients who had more than 1 such bleed remained on twice-weekly dosing. The primary efficacy assessment was the annualized bleeding rate (ABR), or the annualized number of total bleeds. The median ABRs for the 3 groups during the 26-week period were follows:
- Twice-weekly treatment: 4.1 (range, 2.0 to 10.6)
- Every-5-day treatment: 1.0 (range, 0.0 to 2.0)
- Every-7-day treatment: 3.9 (range, 0.0 to 6.5)
The researchers
"The filing acceptance for BAY94-9027 by the FDA represents a milestone to Bayer in its commitment to seeking potential treatments to address the unmet needs of people living with hemophilia A," said Dario Mirski, MD, senior vice president and head of medical affairs Americas for Bayer. "For more than 25 years, Bayer has been committed to working with the community to support patients and deliver a spectrum of factor VIII products to provide physicians with treatment options for managing their patients with hemophilia A."
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