Epidyolex, the first FDA approved CBD medicine for severe epilepsy in children, received Australian Therapeutic Goods Administration approval.
To bring medicine to Australian patients, GW teamed up with Chiesi Australia.
The UK-based global biopharmaceutical company also collaborated with Australia’s Pharmaceutical Benefits Advisory Committee to obtain reimbursement for the medicine via listing on the Pharmaceutical Benefits Scheme. The medicine was also approved by the US Food and Drug Administration in 2018, by European Commission a year later and, just this month, approved in Scotland.
“This marks our third global regulatory approval and is another important step for GW and the patients we are here to support,” GW COO Chris Tovey said.