Regulators Approve GW Pharmaceuticals' Cannabis-based Epidyolex In Australia

Epidyolex, the first FDA approved CBD medicine for severe epilepsy in children, received Australian Therapeutic Goods Administration approval.

GW Pharmaceuticals plc GWPH confirmed Wednesday that TGA authorized the medicine to treat Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age and older.

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. 

Chiesi Australia’s General Manager, Chris Rossidis, said that this is an “important step forward for the management of LGS and Dravet syndrome,” highlighting that they are working on achieving “greater access to this medicine as soon as possible.”

The FDA recently gave a green light for expanded indications for the drug by adding management of seizures related to tuberous sclerosis complex.

Besides label expansion, the US regulatory body also expanded the age range in all approved indications, including patients of one year of age and older.

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