European patients with the haemophilia A could soon get access to a new treatment option after regulators approved Bayer’s Kovaltry for all age groups.

Kovaltry (octocog alfa; BAY 81-8973) is an unmodified full-length recombinant factor VIII product, which has demonstrated control of and protection from bleeds in haemophilia A patients when administered prophylactically two or three times per week. 

Approval came on the back of findings from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Haemophilia A Disease) Clinical Development Program, comprised of three clinical trials showing the drug’s pharmacokinetics, efficacy and safety.

Findings from LEOPOLD II, for example, showed a 93.3% reduction in median annualised bleeding rate (ABR) in patients taking Kovaltry twice a week in the prophylaxis arm versus on-demand treatment and a 96.7% reduction in the three-times-per-week arm versus on-demand.

Hemophilia A affects 1 in 10,000 males, including more than 30,000 in Europe. The condition can cause prolonged or spontaneous bleeding over time, and new treatment options - particularly with flexible dosing - are needed to enable doctors to better match the right treatment to the right patient.