Bayer’s Kovaltry gains EU approval for haemophilia A

Bayer has announced the European Commission approval of its haemophilia A treatment Kovaltry, following results from the LEOPOLD clinical development programme.

The unmodified, full-length recombinant factor VIII candidate demonstrated an ability to control and protect against bleeds when used prophylactically two or three times per week.

The LEOPOLD (Long-Term Efficacy Open-Label Programme in Severe Haemophilia A Disease) study comprised three multinational clinical trials investigating the pharmacokinetics, efficacy and safety of Kovaltry across a population of 200 children and adults with severe haemophilia A. The participants came from 60 different sites and 25 countries around the world.

Dr Joerg Moeller, member of the executive committee of Bayer AG’s Pharmaceutical Division and head of development, hailed the decision: “This approval is the next milestone in our long-term effort to bring new and innovative treatments to the market.”

Professor Johannes Oldenburg, chairman and director of the Institute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, hailed the flexibility of Kovaltry, stating that it allowed treatment to be tailored to the “specific need of each person affected by haemophilia A”.

Kovaltry’s EU approval follows its recommendation in December last year from the European Committee for Medicinal Products for Human Use (CHMP) and Bayer is now working on gaining regulatory approvals for worldwide markets.

The haemophilia drug market has seen plenty of action in the last year alone, with Roche’s ACE910 gaining breakthrough status from the FDA and Biogen’s Elocta gaining European approval for the treatment of haemophilia A, while Novo Nordisk began development of a haemophilia B candidate.

Bayer itself is no stranger to the international haematology market, however, with current recombinant anti-haemophilic factor drug Kogenate available in more than 70 countries and another recombinant factor VIII candidate currently in the pipeline.

Bayer is also looking into factor VIII gene therapy and tissue factor pathway inhibitor (TFPI) inhibition for the treatment of haemophilia and other blood disorders.

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