Will trump's fda relax standards for drug approval? We'll get a clue soon with decision on portola's anticoagulant
- Select a language for the TTS:
- UK English Female
- UK English Male
- US English Female
- US English Male
- Australian Female
- Australian Male
- Language selected: (auto detect) - EN
Play all audios:
Is the FDA under new Commissioner Scott Gottlieb willing to be flexible with the rules, and maybe even lower regulatory standards a wee bit, to approve new drugs? It’s a question that will
be partially answered in the coming days when the FDA hands down a decision on betrixaban, a new anticoagulant developed by Portola Pharmaceuticals. Portola is asking the FDA to approve
betrixaban to reduce the risk of dangerous blood clots in patients who are leaving the hospital after treatment for a medical (as opposed to a surgical) illness. The betrixaban clinical
data, however, are messy. The drug failed to significantly reduce blood clots, when compared with placebo, in its sole phase 3 clinical trial. Normally, a negative study would stall an FDA
submission, but Portola pushed ahead anyway, offering an alternative interpretation of the data. An FDA decision on betrixaban could come Friday or Monday. (The FDA’s official decision
deadline is Saturday, June 24.) STAT+ Exclusive Story Already have an account? Log in THIS ARTICLE IS EXCLUSIVE TO STAT+ SUBSCRIBERS UNLOCK THIS ARTICLE — PLUS DAILY COVERAGE AND ANALYSIS OF
THE BIOTECH SECTOR — BY SUBSCRIBING TO STAT+. Already have an account? Log in Individual plans Group plans View All Plans To read the rest of this story subscribe to STAT+. Subscribe