Bayer’s new haemophilia A drug obtains FDA approval

Bayer Pharmaceuticals Americas Region president Carsten Brunn said: "Jivi’s proven efficacy with its unique dosing regimen is an important benefit to patients that we look forward to bringing to the global community, as we pursue additional regulatory approvals for Jivi in other regions around the world."

The FDA’s decision is based on data obtained during a phase II/III PROTECT VIII clinical trial conducted over 36 weeks.

The trial investigated Jivi’s safety, efficacy and pharmacokinetics for prophylactic dosing, on-demand treatment and perioperative management.

Data showed that patients administered with the haemophilia A drug experienced bleed protection and safety of up to a median of 1.9 years.

The drug was found to be well-tolerated in most of the adult and adolescent clinical trial participants. During the studies, the most frequent adverse reactions were headache, cough, nausea and fever.

In addition to the FDA, Bayer has submitted applications seeking marketing authorisations for BAY94-9027 to treat haemophilia A in the European Union and Japan.