The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the antiepileptic lacosamide UCB (UCB Pharma SA) for partial-onset seizures.
This was an informed consent application, which makes use of data from the dossier of a previously authorized medicine. The reference product for lacosamide UCB is Vimpat (UCB).
"Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adults, adolescents and children from 4 years of age with epilepsy," the EMA said in a statement.
Lacosamide UCB will be available as a 10-mg/mL solution for infusion, a 10-mg/mL syrup, and film-coated tablets in strengths of 50 mg, 100 mg, 150 mg, and 200 mg. The most common side effects are dizziness, headache, diplopia, and nausea.
Detailed recommendations for use of this product will be published in the European public assessment report after the European Commission grants full marketing authorization.
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Cite this: CHMP Backs Generic Lacosamide UCB for Partial-Onset Seizures - Medscape - Jun 28, 2019.