FDA issues Eisai with ‘refuse to file’ letter for epilepsy drug
July 29th, 2011 // 1:00 pm @ jmpickett
Eisai has suffered a setback with the news that regulators in the USA have turned down the Japanese drugmaker’s submission for its new antiepileptic perampanel.
The US Food and Drug Administration has issued a ‘refusal to file’ letter in response to the company’s New Drug Application for perampanel. The drug, which is also known as E2007, is a first-in-class highly selective non-competitive AMPA-type glutamate receptor antagonist and has been developed for the treatment of partial-onset seizures associated with epilepsy.
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The FDA has requested “reformatting and reanalyses of some datasets in the dossier to assist with a substantive review”, Eisai noted, adding that it believes that “no new non-clinical or clinical studies are required to support this filing”.
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Eisai files epilepsy treatment perampanel Success for Eisai s antiepileptic Zonegran as monotherapy
The Tokyo-based firm went on to note that the FDA’s letter does not comment on the approvability of the drug, “and no determination has been made with regard to the efficacy or safety of perampanel”. Eisai concluded by saying that it will work closely with the agency to “provide the information requested for resubmission of this application as quickly as possible”.
EMA to look at Zonegran as monotherapy
In better news for Eisai, the European Medicines Agency has accepted for review their application to extend the use of Zonegran (zonisamide) as monotherapy for newly-diagnosed epilepsy patients with partial seizures, with and without second generalisation. It is currently approved in the European Union as an adjunctive therapy in the treatment of partial seizures.
Bettina Bauer, head of the EU Epilepsy Business Unit at Eisai Europe, said that “as a research-based pharmaceutical company with a particular focus on epilepsy, we are not only committed to bringing innovative new therapies to market, but also ensuring that we maximise the clinical benefits of our currently-licensed products”. She added that “if approved as monotherapy zonisamide will offer newly diagnosed epilepsy patients a new option to help improve their seizure control”.
