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

The age range has been expanded to include patients one year of age and older who experience seizures.

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® oral solution to treat seizures associated with tuberous sclerosis complex 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.1 EPIDIOLEX, the first plant-derived cannabinoid prescription medicine and the only FDA-approved form of cannabidiol 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.

Based on previous positive trial results in TSC patients, EPIDIOLEX may become an important treatment option for patients.Elizabeth Thiele, M.D., Ph.D., Director of the Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital

"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."

"It is a new tool in the toolbox for physicians and could meet a significant unmet need," said Elizabeth Thiele, M.D., Ph.D., Director of the Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital, Professor of Neurology at Harvard Medical School and clinical investigator. "Nearly two-thirds of individuals with TSC develop treatment-resistant epilepsy and there is a need for new options that may benefit these patients who often try and fail existing treatments."

The Company anticipates most payers will quickly update their EPIDIOLEX coverage policies to include TSC at access levels similar to that of LGS and Dravet syndrome.

"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."

FDA approval includes a recommended maintenance dose of 25 mg/kg/day for TSC patients, which is supported by data from a Phase 3 safety and efficacy study evaluating 25 mg/kg/day of EPIDIOLEX. The study met its primary endpoint, which was the reduction in seizure frequency compared to a baseline of Epidiolex vs placebo, with seizure reduction of 48 per cent in patients taking Epidiolex 25 mg/kg/day compared with 24 per cent for placebo (p<0.01).  All key secondary endpoints were supportive of the effects on the primary endpoint. The most common adverse events in those receiving EPIDIOLEX in the study (≥10 per cent and greater than placebo) included diarrhea; transaminase elevations; decreased appetite; somnolence; pyrexia; and vomiting. The safety profile observed in this study was generally comparable to that observed in prior studies of Epidiolex.

To learn more about GW Pharmaceuticals, visit the company HQ here.

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Casey Peternell
Casey Peternell

Casey is a media and content creator with a keen eye for creativity. Casey is currently in the process of obtaining a double bachelors degree in Media & Communications and Business from Swinburne University in Melbourne.

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