CHMP requests more information on betrixaban VTE MAA

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said EMA’s CHMP requested additional information related to its MAA for betrixaban (PRT054021) for extended-duration prophylaxis of venous thromboembolism (VTE) in adults with acute medical illness and risk factors for VTE.

Portola did not disclose details but said it believes CHMP's questions, which were provided in a Day 195 list of outstanding issues, can be addressed with existing clinical data. The company's responses are due Jan. 23 and it expects CHMP to issue an opinion no later than next quarter...