Can Praxbind Push Pradaxa Ahead?
This article was originally published in The Pink Sheet Daily
Executive Summary
Approval of antidote should give Boehringer Ingelheim’s anticoagulant a needed advantage in a tough market, but it has a short window before Portola’s Factor Xa antidote comes along.
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Portola Finally Gets FDA OK For Factor Xa Antidote AndexXa
It has taken a while and there were concerns that another trial may be needed before approval but AndexXa has got the green light in the US as a reversal agent for Eliquis and Xarelto. It comes with a warning and post-marketing commitments but Portola has very high hopes.
Portola May Need Randomized Trial For AndexXa Approval. The Question Is When
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.
Portola Seeks Narrower Label For AndexXa Antidote After FDA Rebuff
Company had wanted accelerated approval for the antidote for all Factor Xa inhibitors, but will now focus the reversal agent on the two drugs commanding the largest markets – Bristol/Pfizer's Eliquis and J&J/Bayer's Xarelto.