BioCentury
ARTICLE | Clinical News

FDA may require additional trial of Portola's AndexXa

March 2, 2018 5:55 PM UTC

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) lost over $700 million in market cap on March 1 after it disclosed late on Feb. 28 that FDA may require an additional randomized study of AndexXa andexanet alfa to reverse the anticoagulant activity of Factor Xa inhibitors.

During Portola's earnings conference call Feb. 28, CEO William Lis said the company "didn't get clarity" from FDA on its trial request, such as whether the trial would be pre- or post-approval. He said the agency did confirm that a resubmitted BLA for AndexXa is still being reviewed for accelerated approval with the same May 4 PDUFA date as disclosed in December...