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Bayer wins US FDA approval for Jivi for the routine prophylactic treatment of haemophilia A patients.

M2 EQUITYBITES-August 31, 2018-Bayer wins US FDA approval for Jivi for the routine prophylactic treatment of haemophilia A patients

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Health care company Bayer revealed on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for Jivi for the routine prophylactic treatment of haemophilia A in previously treated adults and adolescents 12 years of age or older.

In haemophilia A, the most common type of haemophilia, blood clotting is impaired as a result of a lack or defect of coagulation factor VIII. Patients therefore repeatedly experience bleeds in muscles, joints or other tissues, which can result in chronic joint damage and can have serious consequences if not treated appropriately.

The company said Jivi (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) is a replacement therapy that replaces the reduced or missing FVIII (a protein needed to form blood clots) in haemophilia A patients. Jivi has a half-life of 17.9 hours, an injectable medicine and the initial recommended prophylactic regimen is twice weekly with the ability to dose every five days and further individually adjust to less or more frequent dosing based on bleeding episodes.

This US FDA approval of Jivi is supported by results of the company's pivotal Phase 2/3 PROTECT VIII trial comprised of prophylactic dosing, on-demand treatment and perioperative management in adults and adolescents 12 years of age or older with severe haemophilia A. One hundred and twenty-six patients completed the main study.

According to the company, the treatment with Jivi was well tolerated in the majority of adult and adolescent patients in clinical trials.

Additionally, the company has submitted marketing authorisation applications for BAY94-9027 for the treatment of haemophilia A in the EU and Japan.

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Publication:M2 EquityBites (EQB)
Date:Aug 31, 2018
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