Bayer submits marketing authorisation application for haemophilia A product

Bayer HealthCare submitted an application for marketing authorisation to the European Medicines Agency (EMA) for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of haemophilia A in children and adults. BAY 81-8973 is a full-length recombinant Factor VIII that has demonstrated clinical evidence of efficacy when used for prophylaxis 2 or 3 times per week, with typical dosages. (1) Bayer plans to file BAY 81-8973 for approval in other countries in the coming months.
Source: Pharmacy Europe - Category: Drugs & Pharmacology Authors: Tags: *** Editor's Pick Clinical trials Practical therapeutics Industry News Haematology Patient care BAY 81-8973 blood coagulation proteins haemophilia a Latest News LEOPOLD II trial low-dose prophylaxis regimen recombinant Factor VIII Source Type: news