FDA Approves CBD Meds From GW Pharmaceuticals To Treat Seizures

GW Pharmaceuticals plc GWPH and Greenwich Biosciences Inc. jointly announced FDA approval for EPIDIOLEX, an oral solution aimed to manage seizures related to tuberous sclerosis complex.

The companies said the age range includes patients one year of age and older.

Besides the new indication, EPIDIOLEX, which is plant-derived CBD medicine, can also help those suffering from seizures linked to Lennox-Gastaut and Dravet syndromes.

Initially, the medicine is approved by the FDA for treating both syndromes in patients two years of age and older, the press release said.

GW obtained the European Union’s approval for the medicine, under the trade-name EPIDYOLEX.

The medicine is available to patients by a physician’s prescription.

GW CEO  Justin Gover encourages those with TSC to seek the medicine.

“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,” he said.

Director of the Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital and Professor of Neurology at Harvard Medical School and clinical investigator, Elizabeth Thiele, M.D., Ph.D. explained the around two-thirds of individuals with TSC are prone to developing treatment-resistant epilepsy, highlighting there is a “need for new options.”

“Based on previous positive trial results in TSC patients, EPIDIOLEX may become an important treatment option for patients,” Thiele said.

Kari Luther Rosbeck, Tuberous Sclerosis Alliance’s President and CEO, seconded Thiele’s opinion, adding that “FDA approval of EPIDIOLEX in TSC is a tremendous step.”

Courtesy photo