Monotherapy Filing For Lamotrigine In UK
Wellcome has applied for approval to market its anticonvulsant drug Lamictal (lamotrigine) for use as a monotherapy for adult epilepsy in the UK. The drug is licensed as an add-on treatment for seizures not controlled with other antiepileptics.
The company said that results of studies and clinical practice information has shown that the compound is as effective as established therapies (eg carbamazepine and phenytoin) and has a lower side effect profile than these drugs. Rash tended to be the commonest side effect, but this could be reduced by starting with a low dose and titrating upwards.
The company told the Marketletter that submissions have been made for a monotherapy indication in 13 countries in Europe and Australasia; the first of these approvals is expected to be in the UK by the end of this year. And Wellcome said that it expects the drug to be approved in the USA as an add-on therapy for adult epilepsy before the end of the year.
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