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Europe approves Bayer haemophilia drug

Published on 22/02/16 at 01:02pm

Bayer has received approval from the European Commission for its haemophilia A drug Kovaltry (octocog alfa) in patients of all age groups, allowing it to market the product in all 28 EU member states.

Kovaltry is an unmodified full-length product, that has demonstrated control of, and protection from, bleeds in haemophilia A patients in 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, 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.”

“Haemophilia treatment has advanced considerably over the past decades; however, there is more that can be done to improve patients’ quality of life,” adds Prof Dr Johannes Oldenburg, chairman and director of the Institute of Experimental Hematology and Transfusion Medicine, University Clinic Bonn. “The demonstrated efficacy of two and three times per week prophylactic treatment provides the flexibility to tailor the treatment to the specific need of each person affected by haemophilia A.”

As well as a recombinant factor VIII products, which involve injecting concentrated of blood plasma and genetically engineered cells known as recombinants into the bloodstream to prevent or control bleeding, 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.

Some 400,000 people worldwide are affected by haemophilia - a largely inherited condition in which 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.

Joel Levy

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