FDA Approves EPIDIOLEX (cannabidiol) Oral Solution to Treat Seizures Associated with Tuberous Sclerosis Complex

– Age-range for all EPIDIOLEX indications expanded to include patients one year of age and older –

– Third indication approved for EPIDIOLEX, the only FDA-approved Cannabidiol (CBD) medicine –                   

CARLSBAD, Calif., Aug. 03, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with its U.S. subsidiary Greenwich Biosciences, Inc., today announced the U.S. Food and Drug Administration (FDA) has approved EPIDIOLEX (cannabidiol) oral solution 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 (LGS) 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.¹ EPIDIOLEX, the first plant-derived cannabinoid prescription medicine and the only FDA-approved form of cannabidiol (CBD), was initially approved by the FDA in June 2018 for the treatment of seizures associated with LGS or Dravet syndrome in patients two years of age and older. GW has also received approval for this medicine in the European Union under the tradename EPIDYOLEX and a TSC EMA submission is currently under review.

“FDA approval of this new indication is exciting news for those with refractory seizures due to tuberous sclerosis complex,” said Justin Gover, GW’s Chief Executive Officer. “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.”