Cannabis medicine Epidyolex registered in Australia
On 21 September 2020, the Therapeutic Goods Administration registered Epidyolex® on the Australian Register of Therapeutic Goods (ARTG).
Epidyolex® is a cannabidiol only product developed by United Kingdom based company GW Pharmaceuticals. It has been approved by the TGA for treatment of seizures associated with Lennox-Gastaut syndrome or Dravet Syndrome for patients two years of age and older.
NSW Government funded research on the use of Epidyolex® for the treatment of paediatric epilepsy provided evidence to support the product being registered. Further details about these trials can be found on the Clinical Trials section of this website.
As registration on the ARTG is a pre-requisite for Australian Government funding through the Pharmaceutical Benefits Scheme, this may eventually lead to reduced out of pocket costs for patients.
Epidyolex® is the first cannabidiol only cannabis medicine to be registered on the ARTG. The only other cannabis medicine registered in Australia is Sativex®, which is the medicine nabiximols which is a mix of various cannabinoids, approved for treatment of spasticity associated with multiple sclerosis.