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Roche's hemophilia therapy Hemlibra gets Japanese approval

Chugai Pharmaceutical Co. Ltd. said Japan's Ministry of Health, Labour and Welfare approved Hemlibra for treating hemophilia A.

The Japanese drug regulator allowed the use of an injection of Hemlibra, also known as emicizumab, to prevent or reduce bleeding episodes in patients with hemophilia A.

The approval was based on results of the Haven 1 and Haven 2 studies of Hemlibra in patients with hemophilia A.

Hemlibra received approval from the U.S. Food and Drug Administration in November 2017 and from the European Commission in February 2018.

About 5,000 individuals in Japan suffer from hemophilia A, an inherited disorder in which blood does not clot properly, resulting in uncontrolled bleeding.

Chugai is majority owned by Swiss drugmaker Roche Holding AG.