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Home Industry News Eisai receives CHMP recommendation for new Fycompa approval

Eisai receives CHMP recommendation for new Fycompa approval

29th May 2015

Eisai has received a recommendation for European regulatory approval of Fycompa in a new epilepsy indication.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the drug for use as an adjunctive treatment for primary generalised tonic-clonic (PTGC) seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.

This backing was based on data from a clinical trial that demonstrated the efficacy and safety of adjunctive Fycompa therapy in 164 patients aged 12 years and older receiving one to a maximum of three antiepileptic drugs.

PGTC seizures are one of the most common and most severe forms of generalised seizures, accounting for approximately 20 percent of all epilepsy cases.

The company said: "Eisai seeks to make continued contributions to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families."

It comes after the firm recently announced positive phase III clinical trial data demonstrating the efficacy of another of its antiepileptic drugs, Zebinix, in the treatment of elderly epilepsy patients.ADNFCR-8000103-ID-801789201-ADNFCR

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