Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Biosimilars Deals 2024
Diversity
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
PipCast®
PTE
Trade Marks
Webinars

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.   Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”.  Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Get our Pearce IP Blogs & BioBlast® sent directly to your inbox

Subscribe to our Pearce IP Blogs and BioBlast® to receive our updates via email.

Our Latest News