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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

Executive Lawyer, Patent Attorney & Trade Mark Attorney

Naomi is recognised as one of Australia’s leading patent lawyers in virtually every notable legal guide and directory.  Naomi is also Lawyers Weekly Women in Law Partner of the Year (SME Law) for 2021, and the Founding Principal of Pearce IP, which was recognised as the IP Team of the Year in the Australian Law Awards in December 2021.

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

Emily Dwyer

Emily Dwyer

Graduate Lawyer, Trainee Trade Mark Attorney

Pearce IP’s law graduate Emily Dwyer offers legal and intellectual property services, with particular focus on patents and trade marks.

Emily co-authors Pearce IP’s blogs including the biopharma focussed blog BioBlast®, and Pearce IP’s regular pharma/biopharma industry news updates, and ensures that Pearce IP’s life sciences clients are kept abreast of important industry and legal developments.

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