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The Committee for Medicinal Products for Human Use (CHMP) authorised three drugs for the treatment of epilepsy last week: Levetiracetam Actavis, Levetiracetam Accord and Matever (all 250mg, 500mg, 750mg and 1000mg; Matever also 100 mg/ml concentrate for solution).
The active substance of all three drugs is levetiracetam, an antiepileptic (N03AX14). Levetiracetam is a pyrrolidone derivative chemically unrelated to existing antiepileptic active substances.
The exact mechanism by which levetiracetam acts to treat epilepsy is unknown, however the drug binds to a synaptic vesicle protein, SV2A, which is believed to impede nerve conduction across synapses.
In vitro and in vivo experiments suggest that levetiracetam does not alter basic cell characteristics and normal neurotransmission.
Levetiracetam Actavis, Levetiracetam Accord and Matever are generics of Keppra, which has been authorised in the EU since 29 September 2000. Studies have demonstrated the satisfactory quality of the drugs and their bioequivalence with the reference product Keppra.
“Levetiracetam Actavis, Levetiracetam Accord and Matever are indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy,” the report states.
They are indicated as adjunctive therapy:
• in the treatment of partial onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy.
• in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
• in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy”.
The Committee for Medicinal Products for Human Use
