NO FDA Approval Yet for Andexanet

Stephan Moll, MD writes… The FDA did NOT approve Andexanet (brand names: AndexXa™ in the US, IndexXa™ in Europe) in a decision on August 18^th, 2016.  Andexanet is the antidote in clinical development to reverse the anticoagulant effect of Eliquis® (rivaroxaban), Savaysa® (edoxaban), Xarelto® (rivaroxaban) and Lovenox® (enoxaparin).  The FDA is said to have requested more information from the company (Portola) making Andexanet, specifically (a) additional information related to manufacturing of the drug, and (b) more data to support inclusion of Savaysa® and Lovenox®  in the label.  The FDA also wants to finalize its review of the company’s proposals for post-marketing data collection on the performance of the drug.

It needs to be seen when the company (Portola) submits the requested additional information to the FDA and when a new decision from the FDA is then to be expected.  My guess is that this will be sometime in 2017.

References

1. Portola announcement from Aug 18, 2016: http://bit.ly/2c1wKaK
2. Connolly SJ et al. Andexanet alfa for acute major bleeding associated with factor Xa inhibitors. NEJM 2016;Aug 30 [e-pub]
    (http://dx.doi.org/10.1056/NEJMoa1607887)

Disclosure:  I have consulted for Portola, Janssen, and Boehringer-Ingelheim.

Last updated: Aug 31^st, 2016