FDA Approves New Drug for Adults and Adolescents With Hemophilia A

A new long-acting treatment for hemophilia A has been approved for previously treated patients, aged 12 years and older. Bayer’s Jivi was also approved for on-demand treatment and the perioperative management of bleeding in the same population.

The treatment is initially recommended twice weekly with the ability to dose every 5 days and be individually adjusted to less or more frequent dosing based on bleeding episodes. The drug was approved based on results from the phase 2/3 PROTECT VIII trial.

"As a physician who treats hemophilia A patients with a range of individualized 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," Mark Reding, MD, the lead investigator on PROTECT VIII and associate professor of medicine at the University of Minnesota, said in a statement. "Jivi is a welcome option that addresses a growing patient need to integrate treatment with personal lifestyles."

The PROTECT VIII trial was a 36-week, international, open-label trial that demonstrated bleed protection and safety of up to a median of 1.9 years. Jivi replaces the reduced or missing factor VIII in patients older than age 12 who have hemophilia A. The most frequently reported adverse reactions were headache, cough, nausea, and fever.

Read more about PROTECT VIII.

"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,” said Carsten Brunn, president, Bayer Pharmaceuticals, Americas Region.

Bayer has also submitted marketing authorization applications for BAY94-9027 for the treatment of hemophilia A in the European Union and Japan.