The CBD drug derived from the GW Pharmaceuticals plant Epidyolex received approval from the Australian Therapeutic Goods Administration (TGA) for used to treat seizures associated with Lennox-Gastaut syndrome and Dravet syndrome for patients 2 years and older.
The agreement is the third major global regulatory approval for Epidyolex, GW said in a press release.
“The TGA approval is further proof that cannabis-based drugs can succeed through extensive randomized placebo-controlled trials and a rigorous evaluation process to reach patients who need them,” said GW Chief Operating Officer Chris Tovey in a statement.
UK-based GW has partnered with Chiesi Australia at Epidyolex and is working “to secure drug reimbursements via its listing on the (Australia) Pharmaceutical Benefits Scheme.”
“We are working closely with the Ministry of Health to achieve greater access to this drug as quickly as possible,” said Chiesi Australia General Manager Chris Rossidis in a release.
In August, the US Food and Drug Administration approved Epidiolex to treat seizures associated with a third medical condition, tuberous sclerosis complex.
Sales of Epidyolex and Epidiolex comprise $ 117.7 million of revenue for GW $ 121.3 million the quarter ended June 30.
Approximately 92% of Epidiolex’s quarterly revenue comes from the United States.
GW Pharmaceutical trades shares as GWPH on the NASDAQ.
to request modification Contact us at Here or [email protected]