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TGA Approves Second Registered Medicinal Cannabis Product

by | Oct 1, 2020

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.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer, Patent & Trade Mark Attorney

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is market leading in the field of pharma/biopharma, biotechnology and animal health.   

Underpinning Naomi’s legal work is a deep understanding of pharma/biopharma industries, resulting from 25+ years' experience, including as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm and as the Founding Principal of Pearce IP.

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