US regulators have approved Bayer’s Jivi (formerly BAY94-9027), a longer-acting Factor VIII therapy designed to reduce the number of infusions necessary to prevent bleeds in patients with Haemophilia A.
The treatment is engineered to potentially prolong FVIII activity in the blood while preserving coagulation activity using site-specific PEGylation technology, where a PEG (Polyethylene glycol) molecule is consistently attached to the factor VIII protein at a specific site.
An extended half-life recombinant factor VIII therapy may result in reduced frequency of infusions for people living with hemophilia A, the firm noted.
The US Food and Drug Administration is allowing use of Jivi for routine prophylaxis of haemophilia A in previously treated adults and adolescents 12 years or older, and also for on-demand treatment and perioperative management of bleeds.
The decision follows data from the Phase II/III PROTECT VIII trial, which demonstrated bleed protection and safety of up to a median of 1.9 years, Bayer noted.
“As a physician who treats hemophilia A patients with a range of individualised needs, Jivi's approved dosing allows me to adjust frequency based on their bleed episodes to maintain protection from bleeds, which is a serious concern among patients," said Mark Reding, PROTECT VIII Lead Investigator and Associate Professor of Medicine at the University of Minnesota. "Jivi is a welcome option that addresses a growing patient need to integrate treatment with personal lifestyles."
"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,” added Carsten Brunn, president of Bayer Pharmaceuticals, Americas Region.
The drug is also currently under review in Europe and Japan.