FDA approves expanded indications for UCB’s Vimpat
More patients with epilepsy have a treatment option following the Food and Drug Administration's approval of an indication expansion for UCB's Vimpat (lacosamide) CV. The agency approved Vimpat as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years old and older, and Vimpat injection for intravenous use in children four years of age and older.
"These approvals underscore UCB's commitment to people living with epilepsy and our focus on finding solutions for specific unmet needs within the epilepsy community," said Mike Davis, head of U.S. Neurology at UCB. "We are pleased that Vimpat is now available as a treatment option for people living with primary generalized tonic-clonic seizures on their journey to seizure control."
Vimpat tablets and oral solution were previously approved to treat partial-onset seizures in adults and children four years and older as monotherapy and adjunctive therapy. Vimpat injection was previously approved for the treatment of partial-onset seizures only in adult patients (17 years of age and older).