GW Pharmaceuticals' (GWPH) cannabidiol (CBD) drug Epidiolex has been granted Food and Drug Administration approval for a new indication. Additionally, its previous approval has been expanded to cover a wider age range of patients.
The company announced Monday morning that the FDA had approved the oral solution of Epidiolex as a treatment for seizures in patients age 1 and older suffering from tuberous sclerosis complex (TSC) -- a rare genetic disorder in which benign tumors can grow throughout the body; the disease can also cause epilepsy.
The FDA also expanded its approval of Epidiolex to treat seizures in patients afflicted with Lennox-Gastaut syndrome or Dravet syndrome, two rare forms of epilepsy. As with TSC, the drug can now be administered to patients with these conditions who are age 1 and older.
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In 2018, Epidiolex (marketed as Epidyolex in Europe) became the first and so far only cannabidiol-derived medication to be granted approval by the FDA. GW Pharmaceuticals is a U.K.-based specialty pharmaceutical company that concentrates on developing and marketing treatments based on CBD.
"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," said CEO Justin Gover.
"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," he added.
Investors seem to agree. In late-afternoon trading on Monday, GW Pharmaceuticals' shares were up by about 4.5%, well outpacing the gains of the broader stock market.
