FDA refuses to file Eisai’s epilepsy drug
pharmafile | August 1, 2011 | News story | Sales and Marketing | Eisai, FDA, epilepsy
The FDA has refused to file Eisai’s epilepsy drug perampanel, saying it needs more information for the treatment.
The FDA has requested reformatting and reanalysis of some datasets in the dossier to assist with a substantive review, but Eisai believes that no new non-clinical or clinical studies will be required to support this filing.
Eisai said the FDA’s letter is “not a comment on the approvability of the drug”, and that the US regulator has no issue with either the efficacy or safety of perampanel.
The Japanese pharma firm said it would now work closely with the FDA to provide the information it has requested as ‘quickly as possible’.
The drug has impressed in recent trials, with a 2010 phase III study showing its effectiveness in reducing median seizure frequency and increasing responder rates versus placebo, the primary outcome measures in the US and the EU, respectively.
Perampanel is a highly selective non-competitive AMPA-type glutamate receptor antagonist, and if approved, will add to the company’s presence in the therapy area.
The company already has three other treatments on the market in Europe: Zonegran, Zebinix and Inovelon.
Earlier this year Eisai confirmed its dedication to the area by extending its partnership with University College London in neuroscience research.
The epilepsy market is currently undergoing a wave of patent expiries however, which will make it difficult for new entrants to the therapy area.
GlaxoSmithKline’s blockbuster Lamictal has already gone off patent, while Johnson & Johnson’s Topomax will follow in 2012.
Ben Adams
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