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.
You may also be interested in...
Company reported only $33,000 in sales for late anticoagulant market entrant Bevyxxa and $2.2m for the antidote Andexxa, leaving a lot of challenges ahead after the retirement of CEO Bill Lis, effective Aug. 1.
Keeping Track: A CRL For Tlando, An Accelerated Approval For AndexXa, And A Burst Of Supplemental Approvals
The latest US drug development news and highlights from our Performance Tracker.
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.