UCB has been boosted by the news that regulators in the USA have approved a supplemental New Drug Application for its epilepsy treatment Vimpat to be used as monotherapy.
Specifically, the US Food and Drug Administration has given the green light to Vimpat (lacosamide)as monotherapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. It is already approved as adjunctive treatment.
UCB also announced that the FDA has approved a new single loading dose administration option for all formulations of Vimpat. Chief medical officer Iris Loew Friedrich said it is the company’s aim “to provide as many patients as possible with various options to reduce their seizures”.
Based on individual patients’ needs, she noted that doctors can also choose between tablets, oral solution or injection of the drug.
Vimpat is already a big earner for UCB, posting first-half revenues of 217 million euros (+17%) and the monotherapy approval should boost that figure as new patients can be initiated on the treatment and patients already on an antiepileptic can be converted to monotherapy.
To support a filing in Europe, UCB is running a study comparing Vimpat to controlled-release carbamazepine as monotherapy.