De Monitor schreef op 18 februari 2020 14:21:
ir.biocryst.com/node/20801/pdfFDA Accepts BioCryst’s NDA for Oral, Once Daily Berotralstat (BCX7353) to Prevent HAE AttacksFebruary 18, 2020
PDUFA date is December 3, 2020
RESEARCH TRIANGLE PARK, N.C., Feb. 18, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the
U.S. Food and Drug Administration (FDA) has accepted and filed its new drug application (NDA) for the approval of oral, once daily berotralstat
(BCX7353) for the prevention of hereditary angioedema (HAE) attacks.
The Prescription Drug User Fee Act (PDUFA) date for the NDA is December 3, 2020.
In the NDA filing acceptance letter, the FDA stated that they are not currently planning to hold an advisory committee meeting to discuss the NDA.
“HAE patients and their physicians tell us they have been waiting for a once daily oral therapy to prevent attacks, and the acceptance of our
submission, with a PDUFA date this year, means their wait is nearly over,” said Jon Stonehouse, chief executive officer of BioCryst. “We are sharply
focused on building out a very experienced commercial team and executing our commercial plan, so we are ready to go fast when we get approval.”