BioCryst submits new drug application to FDA

BioCryst Pharmaceuticals, Inc. 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 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, CEO 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.
(Source: BioCryst)

2020-01-03T13:59:14+01:00December 11, 2019|HAEi News|