GW Pharmaceuticals PLC (NASDAQ: GWPH) shares popped early on Monday morning after the company announced that it received a key approval from the U.S. Food and Drug Administration (FDA). These approvals act as stepping-stones for companies like GW Pharma on the path to commercializing a drug.
Specifically, the approval was for Epidiolex (cannabidiol) to treat seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Along with this new indication, the age range has been expanded to include patients one year of age and older who experience seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.
TSC is a rare disease that causes benign tumors to grow in vital organs of the body and is a leading cause of genetic epilepsy. Epidiolex is the first plant-derived cannabinoid prescription medicine and the only FDA-approved form of cannabidiol.
GW Pharma has also received approval for this medicine in the European Union under the tradename Epidyolex, and a European Medicines Agency submission is currently under review.
The FDA approval was based on a Phase 3 safety and efficacy study evaluating Epidiolex. The study met its primary endpoint, which was the reduction in seizure frequency compared to baseline of Epidiolex versus the placebo, with seizure reduction of 48% in patients taking Epidiolex compared with 24% for the placebo. All key secondary endpoints were supportive of the effects on the primary endpoint.
Management noted that since Epidiolex is already available to patients by physician’s prescription, patients with TSC can immediately access the medication. This label expansion, including the expansion of the age range in all approved indications, further demonstrates that the FDA process can continue to enable broader patient access to appropriately tested regulatory approved cannabinoid medicines.
GW Pharma traded up 2.2% early Monday to $130.49, in a 52-week range of $67.98 to $175.35. The consensus price target is $190.19.