US regulators have issued a green light for Bayer’s Kovaltry for the treatment of haemophilia A in children and adults.
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 programme, 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.
Haemophilia A is the most common type of the disease, characterised by the reduction or absence of factor VIII, affecting around 1 in 10,000 males, including 16,000 in the US today. Over time, the condition can cause prolonged or spontaneous bleeding, especially into the joints, muscles or internal organs.