GW Pharmaceuticals Plc ADS (GWPH)

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GW Pharmaceuticals receives Australian Therapeutic Goods Administration (TGA) approval for EPIDYOLEX® (cannabidiol) for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy

This represents the third successful regulatory approval globally for GW’s plant-derived cannabis-based medicine

LONDON, Sept. 23, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH) (“GW”, “the Company” or “the Group”), a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines, today announces that the Australian Therapeutic Goods Administration (TGA) has approved EPIDYOLEX® (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age and older.

This represents GW’s cannabis-based medicine’s third global regulatory approval, following US Food and Drug Administration (FDA) approval in 2018 and European Commission (EC) approval in 2019. GW has partnered with Chiesi Australia to make this medicine available in Australia, and the Company will now work alongside its partner and Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) to secure reimbursement for the medicine through a listing on the Pharmaceutical Benefits Scheme (PBS).

“GW was founded over two decades ago with a mission to bring cannabis-based medicines to patients with an unmet medical need. We are proud to now be able to bring GW’s cannabidiol to patients in Australia following this approval and our partnership with Chiesi Australia,” said Chris Tovey, GW’s Chief Operating Officer. “This marks our third global regulatory approval and is another important step for GW and the patients we are here to support. The TGA approval is further proof that cannabis-based medicines can successfully go through extensive randomised placebo-controlled trials and a rigorous evaluation process to reach patients who need them.”

“We are delighted to announce the TGA registration of EPIDYOLEX®, an important step forward for the management of LGS and Dravet syndrome. We are working closely with the Department of Health to achieve greater access to this medicine as soon as possible,” said Chris Rossidis, General Manager, Chiesi Australia.

The approval of GW’s cannabidiol is based on results from four randomised, controlled Phase 3 trials. These studies incorporate data from more than 714 patients with either LGS or Dravet syndrome, two rare forms of epilepsy with high morbidity and mortality rates, which place a significant burden on families and caregivers. Many patients with LGS or Dravet syndrome have multiple seizures per day, which puts them at ongoing risk of falls and injury. Despite current anti-epileptic drug treatment, both of these severe forms of epilepsy remain highly treatment-resistant.1,2,3

https://ir.gwpharm.com/news-releases/news-release-details/gw-pharmaceuticals-receives-australian-therapeutic-goods