UCB’s epilepsy drug approved as monotherapy in US
The US FDA has approved a supplemental new drug application (sNDA) for UCB’s Vimpat (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.
This is a new indication for the drug, which is already approved in the US as adjunctive treatment for these patients.
The approval means that UCB’s ‘third generation’ antiepileptic drug (AED) can be used by adults with partial-onset seizures as a monotherapy, and patients already on an anti-epileptic drug can transfer to it.
A new single loading dose administration option for all formulations of Vimpat has also been approved in epilepsy patients aged 17 years and older.
The approval is based on a phase III historical-control conversion to lacosamide monotherapy study in adult epilepsy patients with partial-onset seizures. The study met its primary endpoint, demonstrating that the exit percentage for patients converting to lacosamide 400mg/day was significantly lower than the historical control exit percentage, used as a comparator. Lacosamide 300 mg/day also met efficacy criteria.
In the EU, Vimpat is approved as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients with epilepsy. It is not approved as monotherapy, although a study is underway to support a potential monotherapy filing with the European Medicines Agency.
Epilepsy is a chronic neurological disorder affecting approximately 65 million people worldwide. It is the fourth most common neurological disorder in the US.
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