US FDA moves approval goalposts for GSK/Valeant's ezogabine and Eisai's eribulin; Abbott/Eisai's Humira filed for additional indication in Japan

The US Food and Drug Administration disappointed several companies yesterday by moving the goalposts for approving their drugs by around three months by extending the Prescription Drug User Fee Act (PDUFA) dates for their review.

The PDUFA target date for UK pharma giant GlaxoSmithKline's (LSE: GSK) and USA-based Valeant Pharmaceuticals International's (NYSE:VRX) epilepsy candidate ezogabine has been moved from August 30 to November 30, 2010. The original NDA was filed with the agency on October 30, 2009. The drug is also partnered with Sweden's Meda AB and is know by the generic name retigabine outside the USA.

The FDA has not yet completed the review of the New Drug Application for ezogabine due to the recent submission of a formal (Risk Evaluation and Mitigation Strategy (REMS) for ezogabine, an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial onset seizures. The REMS was requested by the FDA in correspondence dated August 16 and submitted to the FDA on August 26. The companies will continue to work closely with FDA as the Agency completes its review.