Smyrna-based UCB, a global pharmaceutical company, announced that the U.S. Food and Drug Administration has approved VIMPAT (lacosamide) CV as adjunctive therapy.
The therapy is for the treatment of primary generalized tonic-clonic seizures in patients four years of age and older and VIMPAT injection for intravenous use in children four years of age and older. PGTCS is a type of seizure that occurs all over the brain, affecting both sides of the brain from the start, causing muscles to stiffen and convulsions to occur for up to a few minutes.
The PGTCS approval is based, in part, on results of a Phase 3 study recently published in the Journal of Neurology, Neurosurgery & Psychiatry. Adjunctive treatment with VIMPAT resulted in a significantly lower risk of developing a second PGTCS during the 24-week treatment period, with the corresponding risk reduction being 45% and a significantly higher rate of freedom from PGTCS during the treatment period compared with placebo.
People living with generalized tonic-clonic seizures have an increased risk of injury and those who experienced three or more in one year had a 15-fold increased risk of sudden unexpected death in epilepsy.
Results from the Phase 3 study showed that VIMPAT was generally tolerated in patients with Idiopathic Generalized Epilepsy and PGTCS. The most common adverse reactions reported in patients treated with VIMPAT were dizziness (23%), somnolence (17%), headache (14%) and nausea (10%) compared to 7%, 14%, 10%, and 6%, respectively, of patients who received placebo.
Regarding the expanded pediatric population, VIMPAT tablets and oral solution were already 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.
In October 2020, The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for VIMPAT as adjunctive therapy in the treatment of PGTCS in adults, adolescents and children from four years of age with idiopathic generalized epilepsy. Regulatory reviews for use of VIMPAT in the treatment of PGTCS are also underway in Japan and Australia.
For more information, visit www.ucb-usa.com.