Bayer gains EU approval for hemophilia A drug Kovaltry

German pharma major Bayer (BAYN: DE) has received approval from the European Commission of Kovaltry (antihemophilic Factor [recombinant]) for the treatment of hemophilia A in patients of all age groups.

Kovaltry is an unmodified full-length recombinant factor VIII product, that in clinical trials has demonstrated control of bleeds, and protection from bleeds in hemophilia A patients when used prophylactically two or three times per week.

“This approval is the next milestone in our long-term effort to bring new and innovative treatments to the market,” said 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 Hemophilia community and we’re excited to introduce Kovaltry as a new treatment option for patients with hemophilia A,” Dr Moeller added.

Technavio's analysts forecast the global hemophilia A drugs market to expand at a compound annual growth rate (CAGR) of 6.25% over the period 2014-2019. For 2014, the hemophilia market was estimated to be worth around $10 billion.

“Hemophilia treatment has advanced considerably over the past decades; however, there is more that can be done to improve patients’ quality of life,” said Prof Johannes Oldenburg, chairman and director of the Institute of Experimental Hematology and Transfusion Medicine, University Clinic Bonn., noting that “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 hemophilia A.”