FDA rejects Portola's anticoagulant antidote AndexXa

18 August 2016

The US Food and Drug Administration has turned down approval of Portola Pharmaceuticals’ (Nasdaq: PTLA) anticoagulant antidote product for the time being, sending the company’s shares down 11% to $23.69 in regular trading on Wednesday, and the stock was 17.7% lower at $19.50 in pre-market trading today.

The FDA issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa).

An FDA-designated Breakthrough Therapy, AndexXa is in development for patients treated with a direct (apixaban, Bristol-Myers and Pfizer’s Eliquis, rivaroxaban, Bayer’s Xarelto, or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

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