September 27th, 2012

FDA Sets New Decision Date for Eliquis (Apixaban)

The FDA  will decide the fate of apixaban (Eliquis) by March 17, 2013. The new Prescription Drug User Fee Act (PDUFA) goal date was announced yesterday by the drug’s manufacturers, Pfizer and Bristol-Myers Squibb.

The new drug application (NDA) for apixaban for stroke prevention in atrial fibrillation has been delayed twice. Although the pivotal ARISTOTLE trial was highly praised when it was first published, the FDA first extended its review by 3 months and then issued a complete response letter (CRL) on June 25 requesting “additional information on data management and verification from the ARISTOTLE trial.” According to Pfizer and Bristol-Myers Squibb, the FDA has now accepted for evaluation their response to the CRL.

In Europe last week, the Committee for Medicinal Products for Human Use (CHMP) recommended approval for apixaban for the same indication.

4 Responses to “FDA Sets New Decision Date for Eliquis (Apixaban)”

  1. Judith Andersen, AB, MD says:

    Good. There is, at present, no pressing need for a 2nd oral anti-Xa for atrial fibrillation (particularly one that must be taken twice daily). And there have been issues about apixaban safety that arose from its first clinical trials. The FDA dragged its heels with regard to rivaroxaban approval for atrial fibrillation, a drug already approved for orthopedic surgery prophylaxis, which had more pre-clinical and clinical trial data than virtually any other comparable agent — and rightly so. Hy’s rules, common sense, and the absence of an urgent need for a “me-too” agent make the FDA’s caution both tolerable and admirable.

  2. Jean-Pierre Usdin, MD says:

    pros and cons:
    Large progress in patient’s (and physician’s)quality of life!
    However many similar anti thrombotics involved in prevention of arterial thrombo embolic events in non valvular AF.
    Different modalities of prescription in prevention of Thrombo Embolic Venous disease and embolic events from AF. This may conduct to confusions and frequent P.D.R. searches(Physician Desk References)(as Vidal dictionary in France).

  3. Dan Hackam, MD PhD says:

    It would be good to have access to a fourth oral anticoagulant (after warfarin, dabigatran and rivaroxaban), because this will drive prices down due to competition between pharmaceutical companies. In addition, rivaroxaban for AF is suspect. A short-acting drug needs to be dosed BID; the TTR in the control arm of the trial was very poor; and there was a large increase in stroke/death at the end of the trial in the rivaroxaban arm. I will not use rivaroxaban until these issues are cleared up.

    Apixaban has several advantages over competitors. It is the only agent that actually reduce all cause mortality over warfarin in any of the landmark trials, and it has two such trials (AVERROES and ARISTOTLE), which provides nice external validation of its dataset. It is compatible with renal insufficiency and in fact there actually was decreased bleeding on apixaban vs warfarin in those with poor kidney function (recent ESC presentation and hotline EHJ paper), suggesting a strong statistical interaction between renal function and apixaban allocation in terms of major hemorrhage. I suspect it will be the preferred anticoagulant once it is approved.

  4. David Powell , MD, FACC says:

    I agree that there will be a niche for apixaban. The bleeding does appear less (no difference compared with aspirin in AVERROES).
    The relative bleeding reduction appears more prominant among CKD patients. But note that patients were excluded if GFR80, (2) wgt 1.5. Only 1.5% of the patients had GFR<30.
    Troubling for some may be that ischemic strokes (the very point of treatment) were not significantly decreased by apixaban.
    Nevertheless, I will likely utilize the drug in those at higher bleeding risk and those intolerant to dabigatran.