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Eisai has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its new epilepsy treatment Fycompa.
If approved, the treatment will be the first epilepsy product of its kind to gain regulatory approval.
The drug provides adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, for patients aged 12 or older.
It is derived from perampanel, a chemical entity discovered and developed by Eisai.
The CHMP based its decision on the latest phase III results, which found that Fycompa delivered favourable results when used as an adjunctive treatment in cases involving partial-onset seizures.
Another prospective benefit of the drug is that it is to be taken once-daily by patients, thereby encouraging them to follow a lengthy course of treatment.
Eisai also received a positive opinion from the CHMP for Zonegran, another epilepsy treatment developed to help patients newly diagnosed with the condition.
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