String of Japanese drug approvals

In what was clearly an active session for the Japanese Ministry of Health, Labor and Welfare (MHLW), four new drug approvals were announced this morning.

First up, Japan’s Astellas Pharma (TYO: 4503) today announced that Xospata (gilteritinib) tablets 40mg, a FLT3 (FMS-like tyrosine kinase 3) inhibitor received manufacturing and marketing approval for the treatment of FLT3 mutation-positive relapsed or refractory acute myeloid leukemia (AML) in Japan. The drug is currently under review with the US Food and Drug Administration.

Germany’s Bayer (BAYN: DE) today said that the MHLW has approved Jivi (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.