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.