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Portola May Need Randomized Trial For AndexXa Approval. The Question Is When

 
• By Emily Hayes

Randomized trial represents higher bar for US approval of reversal agents for novel anticoagulants than expected – and if needed prior to approval, could delay AndexXa launch for two or maybe even four years.

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Portola Pharmaceuticals Inc. may need a randomized trial for US approval of its AndexXa (andexanet alfa) antidote for Factor Xa anticoagulants, raising concerns that this would be needed prior to approval, delaying launch by years.

The company disclosed FDA's potential request during its earnings call on Wednesday, Feb. 28, after the market closed, noting that...

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