BioCryst Submits New Drug Application for Oral, Once Daily Berotralstat (BCX7353) to Prevent HAE Attacks

RESEARCH TRIANGLE PARK, NC, USA I December 11, 2019 IBioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of oral, once daily berotralstat (BCX7353) for the prevention of hereditary angioedema (HAE) attacks.

“HAE patients are waiting for a safe, effective oral therapy to manage their disease and this NDA submission brings berotralstat an important step closer to meeting this need for patients and their physicians,” said Jon Stonehouse, chief executive officer of BioCryst.

“Thank you to all of the HAE patients who have participated in our clinical trials, to the clinical investigators and their teams around the world who conducted our clinical trials, and to the BioCryst team for always remembering that patients are waiting for our oral, once daily medicine. Our commercial team is hard at work preparing to commercialize berotralstat in 2020,” Stonehouse added.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at

SOURCE: BioCryst Pharmaceuticals

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