GW Pharmaceuticals Applies for FDA Approval for Epidiolex to Treat TSC

GW Pharmaceuticals Applies for U.S. Marketing Approval for Epidiolex for the Treatment of TSC

Photo: Justin Gover, CEO of GW Pharmaceuticals

GW Pharmaceuticals and its U.S. subsidiary Greenwich Biosciences have submitted a marketing application to the U.S. Food and Drug Administration for Epidiolex, seeking to expand its label to include the treatment of seizures associated with tuberous sclerosis complex, a rare genetic condition.

Epidiolex is currently approved in the United States to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome and has been granted Orphan Drug designation from the FDA for the treatment of tuberous sclerosis complex (TSC).

TSC is a condition that causes mostly benign tumors to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys and lungs, and is a leading cause of genetic epilepsy. TSC is typically diagnosed in childhood and the severity of the condition can vary widely. More than 60 percent of individuals with TSC do not achieve seizure control with standard treatments.

“The submission of this sNDA for Epidiolex is an important step towards the prospect of offering a new treatment option for those patients with TSC who battle difficult-to-treat seizures,” said CEO Justin Gover. “Having already obtained approval for Epdiolex in the treatment of seizures associated with Lennox-Gastaut Syndrome and Dravet Syndrome, this submission is based on positive phase 3 data showing that Epidiolex reduced TSC-associated seizures, which include both focal and generalized seizures types.”

The supplemental new drug application is based on positive phase 3 data showing that Epidiolex reduced TSC-associated seizures, which include both focal and generalized seizure types. Patients treated with Epidiolex experienced a significantly greater reduction from baseline in TSC-associated seizures compared to placebo: 49 percent vs 27 percent in both dosage groups. The safety profile observed was consistent with findings from previous studies, with no new safety risks identified.

Author: Rare Daily Staff