Bayer: Jivi Approved in Japan for Hemophilia a

Bayer announced today that the Japanese Ministry of Health, Labour and Welfare(MHLW) has approved Jivi(R) (BAY94-9027) for the prophylactic treatment of hemophilia A for adults and adolescents 12 years of age or older in Japan. The recommended usual dose for prophylactic regimens is twice weekly. Jivi can also be dosed once every 5 days or once a week in accordance with the patient’ conditions. Jivi is also approved for on-demand treatment and perioperative management of surgeries. Jivi is a site-specifically PEGylated recombinant Factor VIII (rFVIII) that delivers higher sustained levels of FVIII, which extends the blood’s ability to coagulate for longer.

“Nowadays, people with hemophilia can lead their daily lives with less worry thanks to factor VIII replacement therapies,” said Dr.Teruhisa Fujii, director of the Blood Transfusion Division at the Hiroshima University Hospital. “The approval of Jivi allows certain patients with hemophilia A to preserve coagulation factor levels to prevent bleeding with just one infusion per week. This represents an important improvement, allowing patients more flexibility in their lifestyles.”

“The MHLW approval makes Jivi available to patients with hemophilia A in Japan with an option for once weekly dosing dependent on patients’ individual needs. Jivi can be dosed flexibly based on their previous bleed episodes, whilst maintaining protection from bleeds across all approved regimens,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “Therefore, this approval is an important step forward for people with hemophilia A in Japan. This is the second major approval for Jivi this year following FDA approval in the U.S. in August.”

https://www.marketscreener.com/BAYER-436063/news/Bayer-Jivi-Approved-in-Japan-for-Hemophilia-a-27302159/