Keyword: Portola Pharmaceuticals
So far, Andexxa’s rollout has been limited to a few treatment centers as Portola waits for a final FDA greenlight on its new, large-scale manufacturing process, expected in the first quarter of next year.
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Portola Pharmaceuticals had expected to launch its first drug this year. But those plans have been pushed back as its lead candidate Andexxa, developed to reverse anticoagulation for Factor Xa inhibitors, has received a complete response letter from the FDA.
Portola’s experimental drug betrixaban failed a large, pivotal study back in March. But the biotech says it believes the data are still good enough to win an FDA approval.
