Bayer receives EU approval for new haemophilia drug Kovaltry

Bayer has been granted European regulatory approval for Kovaltry, an unmodified full-length recombinant factor VIII product for the treatment of haemophilia A.

Approved for use in patients of all age groups, Kovaltry has demonstrated control over bleeding in clinical trials, as well as offering protection from bleeds in haemophilia A patients when used prophylactically two or three times per week.

These insights were gleaned from the LEOPOLD clinical development programme, which consisted of three multinational clinical trials involving more than 200 children and adults with severe haemophilia A in 25 countries worldwide.

Bayer will continue to pursue regulatory approval for the drug in other territories as it seeks to further expand its growing haematology portfolio.

Dr Joerg Moeller, head of development and member of the executive committee of Bayer's pharmaceuticals division, said: "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."

This comes after the company's drug Xarelto had its positive risk-benefit profile confirmed by the European Medicines Agency earlier this month.