BioCentury
ARTICLE | Company News

Portola: FDA won't require betrixaban meeting

February 8, 2017 4:24 PM UTC

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said FDA does not plan to hold an advisory committee meeting to discuss an NDA for the company's betrixaban (PRT054021). The agency did not identify any issues during its mid-cycle review that require a meeting, Portola said.

Betrixaban is under Priority Review for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. Its PDUFA date is June 24 (see BioCentury Extra, Dec. 23, 2016)...

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