Bayer has received approval from the US Food and Drug Administration (FDA) for its new haemophilia A drug Jivi (BAY94-9027) as routine prophylactic therapy in previously treated adults and adolescents aged 12 years and above.
The initial recommendation for the drug is a twice weekly regimen allowing dosage for every five days. The dosing can then be made more or less frequent depending on bleeding episodes of individual patients.
Jivi also gained the FDA approval for on-demand treatment and perioperative management of bleeding in the same patient population.
The haemophilia A drug is a recombinant factor VIII (rFVIII) replacement therapy. It replaces the mitigated or missing factor VIII (FVIII) in haemophilia A patients.
Site-specific PEGylation of the drug enables a half-life of 17.9 hours, delivering sustained levels in the blood.
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.