CHMP Backs Use of Generic Antiepileptic Lacosamide Accord

Deborah Brauser


July 21, 2017

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for lacosamide (Lacosamide Accord, Accord Healthcare Ltd) for the treatment of epilepsy in adults and teens aged 16 to 18 years.

The antiepileptic is a generic version of Vimpat (UCB), which was authorized for use in the European Union in 2008 and by the US Food and Drug Administration as monotherapy in 2014, following earlier approval as adjunctive treatment.

The indication for the generic film-coated tablets is as both monotherapy and adjunctive therapy for "partial-onset seizures with or without secondary generalization," with availability in the following doses: 50 mg, 100 mg, 150 mg, and 200 mg.

The drug's active substance selectively increases the slow suspension of voltage-gated sodium channels. Hyperexcitable neuronal membranes are then stabilized.

"It is proposed that Lacosamide Accord is prescribed by physicians experienced in the treatment of epilepsy," writes the CHMP in their opinion summary.

Further recommendations and details will be published in their European public assessment report after the European Commission grants full marketing authorization.

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