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Roche's Hemlibra bags US FDA priority review

Roche Holding AG said the U.S. Food and Drug Administration granted priority review to its supplemental biologics license application for Hemlibra for adults and children with a genetic blood disorder.

The company is looking to expand the medicine's approval to include treatment of adults and children with hemophilia A without factor VIII inhibitors.

Hemophilia A is an inherited, serious disorder in which a person's blood is unable to clot properly, leading to uncontrolled and often spontaneous bleeding. Hemophilia affects about 20,000 people in the U.S., with hemophilia A — in which patients are factor VIII deficient — being the most common form.

Hemlibra, also known as emicizumab-kxwh, is currently only prescribed to those with factor VIII inhibitors.

Factor VIII is an essential blood-clotting protein and people with hemophilia A either lack or do not have enough of it. A serious complication to treatment occurs when patients become resistant by developing antibodies, or inhibitors, which block the replacement factor VIII, making it difficult to control bleeding.

The FDA is expected to make a decision on the application by Oct. 4.

The application is supported by a phase 3 study in which the drug controlled bleeding in the patient population.

Hemlibra is co-developed by Chugai Pharmaceutical Co. Ltd. and Roche's unit Genentech Inc.

Roche is banking on the success of Hemlibra and other key products to offset the company's loss in sales in the U.S. due to biosimilar threats.