Portola's anticoagulant antidote gets EU review

Portola has said European regulators are to review its anticoagulant antidote, IndexXa (andexanet alfa), just days after the US regulator rejected the drug.

California-based Portola said the European Medicines Agency had accepted its filing for the Factor Xa inhibitor antidote.

The company is seeking conditional approval in patients treated with a Factor Xa inhibitor such as Johnson & Johnson/Bayer’s Xarelto (rivaraxoban), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding and for patients requiring urgent or emergency surgery.

Europe’s CHMP has begun its standard 210-day review period. The filing is based on data from two phase 3 ANNEXA studies, and limited efficacy and safety data from the ongoing phase 3b/4 ANNEXA-4 study.

This single arm open-label study is evaluating efficacy and safety data in patients receiving Bristol-Myers Squibb/Pfizer’s Eliquis (apixaban), Xarelto, Daiichi Sankyo’s Lixiana (edoxaban), and Sanofi’s Lovenox (enoxaparin).

Earlier this month, the US Food and Drug Administration rejected the drug, saying it needed additional information from the company on manufacturing as well as inclusion of Xarelto and Lovenox on the label.

The decision sent shares in Portola down from more than $26 to around $19 on the NASDAQ, although they recovered slightly since then.

The rejection of the drug, marketed as AndexXa in the US, means that Boehringer Ingelheim’s Pradaxa (dabigatran) remains the only new anticoagulant on the market with a reversal agent available.

Boehringer’s Praxbind (idarucizumab) was approved in the US in October last year, and since then Pradaxa sales have increased slightly – although Xarelto is still way ahead in terms of annual sales, generating around $4.4 billion in total for Bayer and J&J last year.