U.S. FDA Grants Fast Track Designation for BioCryst’s BCX7353

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for BioCryst Pharmaceuticals, Inc.‘s BCX7353 for the prevention of angioedema attacks in patients with HAE.

Fast Track Designation provides opportunities for frequent interactions with the FDA during development of a product candidate and provides the opportunity for priority review if supported by clinical data at the time of the new drug application (NDA) submission.

“Fast Track Designation from the FDA serves as another indicator of the importance of BCX7353 to meet an unmet medical need for HAE patients in the U.S.,” said Jon P. Stonehouse, President & CEO. “We remain focused on completing the Phase 3 program and preparing for an NDA filing in the second half of 2019.”
(Source: BioCryst)