Epidiolex has received approval from the FDA for the drug to treat another condition. The drug, which is the first FDA approved CBD medication, will be eligible to be prescribed for a third condition.
“FDA approval of this new indication is exciting news for those with refractory seizures due to tuberous sclerosis complex,” said Justin Gover, CEO of GW said in a press release. “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. It also provides hope for these patients and their families and is yet another important milestone for EPIDIOLEX as a first-in-class antiepileptic drug.”
Lennox-Gastaut syndrome and Dravet syndrome were the two seizure disorders that the drug was previously approved to treat. Now, Epidiolex is greenlit to help treat seizures from tuberous sclerosis complex (TSC). The genetic disease affects one in 6,000 people. Patients aged 1-year-old and up will be able to take the drug, which lowers the age by a year for the other conditions as well.
“FDA approval of EPIDIOLEX in TSC is a tremendous step forward and our community applauds this positive development,” said Kari Luther Rosbeck, President and CEO of the Tuberous Sclerosis Alliance. “One of the most challenging and frustrating aspects of TSC are seizures that cannot be effectively controlled by existing medications. New treatment options are desperately needed, and this approval adds another option for those impacted by this difficult disease.”
In clinical trials, Epidiolex greatly outperformed placebos, leading to a significant reduction in the number of seizures that patients experienced. The trial included 224 TSC patients in a double-blind placebo-controlled environment.
The sales of Epidiolex drive the majority of revenue for GW pharmaceuticals. That revenue was already $116.1 million for the last quarter.