GW Pharmaceuticals CBD drug gets regulatory OK in Australia

(A version of this story first appeared at Marijuana Business Daily.)

GW Pharmaceuticals’ plant-derived CBD drug Epidyolex received approval from Australia’s Therapeutic Goods Administration (TGA) to be used in treating seizures related to Lennox-Gastaut syndrome and Dravet syndrome for patients 2 and older.

The approval is the third major global regulatory approval for Epidyolex, GW said in a news release.

“The TGA approval is further proof that cannabis-based medicines can successfully go through extensive randomized placebo-controlled trials and a rigorous evaluation process to reach patients who need them,” GW Chief Operating Officer Chris Tovey said in a statement.

United Kingdom-based GW has partnered with Chiesi Australia on Epidyolex and is working “to secure reimbursement for the medicine through a listing on (Australia’s) Pharmaceutical Benefits Scheme.”

“We are working closely with the Department of Health to achieve greater access to this medicine as soon as possible,” Chiesi Australia General Manager Chris Rossidis said in the release.

The CBD drug was approved in 2018 for use in the United States, where it is branded as Epidiolex, and in Europe in 2019.

In August, the U.S. Food and Drug Administration approved Epidiolex for treating seizures associated with a third medical condition, tuberous sclerosis complex.

Sales of Epidyolex and Epidiolex comprised $117.7 million of GW’s $121.3 million in revenue for the quarter ended June 30.

Roughly 92% of quarterly Epidiolex revenue came from the United States.

GW Pharmaceutical shares trade as GWPH on the Nasdaq.