UCB gets FDA approval for childhood epilepsy treatment

metal logo on signage outside a UCB buildingPhoto courtesy of UCB

UCB, a biopharmaceutical company with its U.S. headquarters in Smryna, announced in a press release that the company has received approval from the Food and Drug Administration (FDA) for an innovative childhood epilepsy treatment.

BRIVIACT® (brivaracetam) CV is approved for both monotherapy or adjunctive therapy in patients one month of age and older with partial-onset seizures.

According to the National Cancer Institute monotherapy is “the use of a single drug to treat a disease or condition,” and adjunctive therapy is “another treatment used together with the primary treatment. Its purpose is to assist the primary treatment.”

UCB’s press release gives the following additional information:

This is the first time that the IV formulation of BRIVIACT will be available for pediatric patients when oral administration is temporarily not feasible and is the only IV formulation FDA approved to treat partial-onset seizures in children one month of age and older in nearly seven years.

According to the Epilepsy Foundation, more than three million people are diagnosed with epilepsy, and more than 100,000 Georgians have a seizure disorder. Childhood epilepsy varies in severity and prognosis and may have profound consequences on development and functioning. Seizure burden can impair cognition with effects being most severe in infancy. Partial-onset seizures can include simple partial seizures where patients remain conscious and experience muscle jerking, stiffening or false senses, as well as complex partial seizures where patients lose awareness, stare blankly, or seem aloof to their surroundings.

The expanded indication of BRIVIACT is significant because despite these elevated challenges, few antiseizure medications are FDA approved for treating partial-onset seizures in this particularly vulnerable patient population.

About UCB in Smyrna

UCB’s international headquarters is in Belgium, with its U.S. headquarters in Smyrna near Windy Hill Road and Cobb Parkway.

The company recently began a $47.5 million expansion which includes 60,000 additional square feet. You can read our coverage about the expansion here and here.

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