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BioCryst seeks US FDA approval for swelling disorder pill


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BioCryst seeks US FDA approval for swelling disorder pill

BioCryst Pharmaceuticals Inc. filed an application with the U.S. Food and Drug Administration for its oral pill berotralstat to prevent severe swelling attacks in patients with a rare genetic disorder.

The Durham, N.C.-based company's new drug application is for berotralstat, or BCX7353, to prevent hereditary angioedema attacks. Hereditary angioedema is a disease characterized by recurrent attacks of severe swelling of the skin and mucous membranes. The most common areas of the body to develop swelling are the limbs, face, intestinal tract and airway.

In May, BioCryst said its oral medicine helped reduce the attack rate in patients enrolled in a late-stage study conducted in the U.S., Canada and Europe.

According to BioCryst CEO Jon Stonehouse, the company is preparing to commercialize the treatment in 2020.