Bayer HealthCare has developed a promising new recombinant factor VIII product for the treatment of haemophilia A in adults and children but is waiting European approval.
The application for marketing authorisation has been submitted to the European Medicines Agency for BAY 81-8973 based on positive results from three phase III clinical trials, involving a total of 2014 subjects.
Clinical Studies into the drug show high-levels of efficacy when used for prophylaxis twice or three times per week with standard dosages. Its capacity for flexible dosing gives greater choice in finding the right option for individual patients.
Bayer also plans to file for approval of BAY 81-8973 in other countries in the coming months.
Dr Joerg Moeller, member of the Bayer HealthCare executive committee and head of global development, said: “The submission of BAY 81-8973 is an important step forward in our efforts to improve treatment options for people with haemophilia.”
The company started work on expanding its manufacturing capabilities for haemophilia A products in Germany earlier this year in order to support the production of this therapy, as well as the long-acting agent BAY 94-9027.