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Bayer Secures FDA Approval for Hemophilia A Treatment, Jivi

Bayer Secures FDA Approval for Hemophilia A Treatment, Jivi

Hemophilia A patients have another treatment option. This morning the U.S. Food and Drug Administration (FDA) gave the nod to Bayer AG’s new treatment, Jivi (BAY94-9027).

The newly approved Jivi is intended for use as a routine prophylactic treatment in adult patients who previously underwent treatment for hemophilia A. One of the benefits of Jivi, according to Bayer, is the variable dosing options for patients. Patients who take Jivi will receive doses twice per week, but the drug is able to be dosed five times per week, Bayer said in its announcement. Jivi was also approved for on-demand treatment and the perioperative management of bleeding in the same population, Bayer said. The company believes this will benefit patients who need help with controlling their bleeds.

Hemophilia A is a genetic blood-clotting disorder that can lead to uncontrolled bleeding. There are about 20,000 people in the United States diagnosed with hemophilia and 320,000 worldwide Hemophilia A is the most common form. People with hemophilia A either lack or do not have enough of a clotting protein called factor VIII. The bleeding, which often occurs in joints, can cause significant pain and can lead to chronic swelling, deformity, reduced mobility and long-term joint damage.

Jivi was developed to potentially prolong factor VIII activity in the blood while preserving coagulation activity. The medication does so by using site-specific PEGylation technology. According to Bayer, 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, Bayer noted when the FDA accepted its Biologics License Application last year.

Joerg Moeller, Bayer’s head of research and development, said Jivi offers “proven efficacy with the potential for reduced infusion frequency.” Moeller said the FDA’s approval of Jivi is an important step forward for hemophilia A patients in the United States. Moeller said Bayer AG is also seeking approval of Jivi in Japan and Europe.

Mark Reding, the lead investigator of the trial and an associate professor of medicine at the University of Minnesota said he treats hemophilia A patients who have a range of individualized needs. Reding said Jivi’s approved dosing levels will allow him to adjust the frequency in which patients are dosed “based on their bleed episodes.” He said that will allow for a maintenance of protection from bleeds, which he noted is serious for patients.

“Jivi is a welcome option that addresses a growing patient need to integrate treatment with personal lifestyles,” Reding said in a statement.

This marks the third hemophilia treatment in the Bayer pipeline.

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