12 December 2017 - Portola Pharmaceuticals today announced that the CHMP of the EMA has requested additional information related to the marketing authorisation application for betrixaban.

The CHMP has provided the Day 195 list of outstanding issues to the company with a request for responses during the next available submission window of 23 January 2018. Based on this new timeline, the Company expects the CHMP to issue an opinion later in the first quarter of 2018.

“We have had a productive ongoing dialogue with the CHMP throughout the MAA process and believe the CHMP questions can be addressed with existing clinical data,” said John T. Curnutte, M.D., Ph.D., executive vice president, research and development. “We look forward to continuing to work with the EMA to address the unmet need in Europe for extended duration prophylaxis of venous thromboembolism in acute medically ill patients.”

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