European Commission Approves Bayer Haemophilia Drug
Bayer has received approval from the European Commission for its haemophilia A drug, Kovaltry (octocog alfa) in patients of all age groups. Thereby allowing it to market the product in all 28 EU member states.
Kovaltry is an unmodified full-length product, that has demonstrated control and protection from bleeds in haemophilia A patients within clinical trials when taken prophylactically.
Specifically, the Commission approved the treatment based on results from the three multinational LEOPOLD clinical trials of more than 200 children and adults with severe hemophilia A from 60 sites and 25 countries worldwide.
“This approval is the next milestone in our long-term effort to bring new and innovative treatments to the market,” says Dr Joerg Moeller, a member of the executive committee of Bayer AG’s Pharmaceutical Division and head of Development. “Bayer has a long-term commitment to the Haemophilia community and we’re excited to introduce Kovaltry as a new treatment option for patients with haemophilia A.”
Bayer says it is also working on alternative treatment approaches, such as factor VIII gene therapy and inhibition of tissue factor pathway inhibitor (TFPI), in haemophilia, as well as in other blood disorders.
Approximately 400,000 people worldwide are affected by haemophilia, which is a largely inherited condition where one of the proteins needed to form blood clots is missing or reduced. Over time, the condition can cause prolonged or spontaneous bleeding especially into the joints, muscles or internal organs.