GW Pharmaceuticals' Epidyolex approved in Australia
Epidyolex, GW Pharmaceuticals' medical CBD oil, has been approved by the European Commission. Therapeutic Goods Administration (TGA), Australia's drug regulatory body, for use in the treatment of epileptic seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients aged 2 and over.
«TGA's approval is further proof that cannabis-based medicines can successfully pass through large randomized placebo-controlled trials and a rigorous evaluation process to reach the patients who need them,» a declared Chris Tovey, GW's Chief Operating Officer.
GW is now working to have its product reimbursed in Australia, by registering it with the Australian Pharmaceutical Benefits Scheme.
«We are working closely with the Ministry of Health to get better access to this drug as soon as possible,» said Chris Rossidis.
Epidiolex, the brand name in the United States, has been approved in 2018 in the United States and in Europe in 2019. It is available under a temporary authorization for use (ATU) in France.
Sales of Epidyolex and Epidiolex accounted for 117.7 million $ of GW's 121.3 million $ revenues for the quarter ended June 30, and 92% of Epidiolex's quarterly revenues came from the United States.
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