Portola nabs FDA approval for once-rejected anti-anticoagulant

May 04, 2018

Portola Pharmaceuticals announced that the U.S. FDA has approved Andexxa, the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations and was approved under the FDA’s Accelerated Approval pathway.

A class of next-generation drugs known as new oral anticoagulants (NOACs) has the potential to take over for Warfarin — the go-to blood thinner. Warfarin’s blood-thinning effects can easily be reversed via vitamin K though, which is important in cases where patients taking the drug need emergency surgery. Without those reversal agents, physicians were initially hesitant to prescribe NOACs. Andexxa, however, offers an antidote to common NOACs, such as Eliquis and Xarelto.

Portola first submitted an NDA for Andexxa late 2015, only to be rejected in August 2016. The FDA noted issues with the drug's manufacturing, proposed label and post-market clinical requirements. The company resubmitted the drug a year later and got a user fee action date of Feb. 3.

Read the press release

 

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