The US Food and Drug Administration (FDA) has cleared a supplemental new drug application (sNDA) for UCB’s Vimpat (lacosamide) C-V as montherapy to treat partial-onset seizures in patients with epilepsy.
Earlier, Vimpat was approved in the US as adjunctive treatment for partial-onset seizures in patients aged 17 years and older.
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In addition, UCB has received FDA approval for new single loading dose administration option for all formulations of Vimpat.
UCB chief medical officer and executive vice-president Dr Iris Loew Friedrich said: "People living with epilepsy have individual needs.
"It’s our aim at UCB to provide as many patients as possible with various options to reduce their seizures."
"Now, physicians and epilepsy patients in the US have more VIMPAT options to treat partial-onset seizures, VIMPAT as an initial monotherapy, converting to VIMPAT monotherapy and VIMPAT as an adjunctive therapy."
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By GlobalDataThe FDA’s monotherapy approval for Vimpat was based on a Phase III historical-control conversion to lacosamide monotherapy study in adult epilepsy patients with partial-onset seizures.
UCB noted that the study reached its primary endpoint, demonstrating that the exit percentage, defined as the estimated percentage of patients meeting pre-defined exit criteria, for patients converting to lacosamide 400mg/day was significantly lower than the historical control exit percentage, used as a comparator.
Vimpat has been approved as adjunctive therapy to treat partial-onset seizures with or without secondary generalisation in adult and adolescent patients aged 16 to 18 years with epilepsy, in the European Union.
