TGA Approves Second Registered Medicinal Cannabis Product
The TGA has approved GW Pharma's Epidyolex® (cannabidiol) as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome for patients over 2 years of age.
Epidyolex® was developed by GW Pharma in partnership with Chiesi Australia and is already approved in the US and EU. The product is subject to additional monitoring under the TGA's Black Triangle Scheme, which encourages the reporting of adverse events associated with new prescription medicines.
This is the second medicinal cannabis product to have been approved by the TGA, and the first since 2012, when Emerge Health's Sativex® was first registered for the treatment of spasticity associated with multiple sclerosis.
TGA's September approval of Epidyolex® follows PBAC's August 2020 deferral of its decision regarding the pre-approval PBS listing of Epidyolex® for the same indications, to enable further consultation with stakeholders.