FDA Provides Response to Eisai New Drug Application
FDA has issued a Refusal to File letter in response to the company's New Drug Application for perampanel.
Eisai Inc., a research-based human health care company, announced last week that the FDA has issued a Refusal to File letter in response to the company's New Drug Application (NDA) for perampanel (E2007), an investigational drug, for the treatment of partial-onset seizures associated with epilepsy which was submitted in May 2011.
Perampanel is a highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered and being developed by Eisai.
Upon preliminary review, the FDA requested reformatting and reanalyses of some datasets in the dossier to assist with a substantive review. Eisai believes that no new non-clinical or clinical studies are required to support this filing. This letter does not comment on the approvability of the d
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