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EU Delays For Portola As CHMP Trend Votes Go Good And Bad

 
• By Alexandra Shimmings

Portola will have to rein in its European sales ambitions as the CHMP gives early verdicts on its Factor Xa inhibitor betrixaban and its reversal agent andexanet. 

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Delays for Portola's products • Source: Shutterstock

Portola Pharmaceuticals Inc.'s Factor Xa inhibitor betrixaban's future in the EU is looking dicey after the EMA's CHMP issued a negative trend vote on the product's marketing application at its meeting this week. On the plus side, it also communicated a positive trend vote on the MAA for its universal Factor Xa inhibitor reversal agent, AndexXa (andexanet alfa), but this too represents a slight delay.

Betrixaban's negative trend vote means it is unlikely the committee will adopt a positive opinion on the company's MAA at...

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