FDA Approves Drug to Treat Primary Generalized Tonic-Clonic Seizures
The US Food and Drug Administration (FDA) granted approval to VIMPAT (lacosamide) CV for use as an adjunctive therapy to treat primary generalized tonic-clonic seizures (PGTCS) among patients aged 4 years or older.
The FDA has also expanded the indication of VIMPAT intravenous injection to treat partial-onset seizures among children aged 4 years or older. Prior to this approval, VIMPAT injection was only approved for the treatment of adult patients aged 17 years or older with partial-onset-seizures.
“The treatment of primary generalized tonic-clonic (convulsive) seizures is challenging, with about one-third of patients still being refractory while on therapy,” said David Vossler, MD, with the Department of Neurology at University of Washington, in a press release. Dr Vossler was an investigator of the safety and efficacy of VIMPAT in treating PGTCS.
“Bolstered by a wealth of data demonstrating VIMPAT’s efficacy and safety, this new indication gives people suffering from PGTCS a chance at freedom from these seizures, which many have never experienced,” Dr Vossler added.
The most commonly observed adverse reaction associated with the use of VIMPAT was dizziness among patients with partial-onset seizures. Dizziness, along with headache, somnolence, and nausea, were commonly reported adverse reactions with VIMPAT among patients with PGTCS. Adverse reactions observed among patients aged 4 to 17 years were similar to those seen among adults. Injection site pain or discomfort, erythema, and irritation were also reported with use of the intravenous formulation of VIMPAT.
UCB’s VIMPAT[®] (lacosamide) CV now approved by FDA in U.S. for primary generalized tonic-clonic seizures and expanded pediatric use for people living with epilepsy. News release. UCB. November 17, 2020. Accessed November 17, 2020. https://www.ucb.com/stories-media/Press-Releases/article/UCB-s-VIMPAT-lacosamide-CV-now-approved-by-FDA-in-U-S-for-primary-generalized-tonic-clonic-seizures-and-expanded-pediatric-use-for-people-living-with-epilepsy