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

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

ADDITIONAL INFORMATION

About GW Pharmaceuticals plc
GW Pharmaceuticals (GW), and U.S. subsidiary Greenwich Biosciences, is a UK-based global biopharmaceutical company that has established a world-leading position in cannabinoid science and medicine. Founded over two decades ago in response to significant unmet patient need, patients remain our key focus and improving their quality of life, our motivation. GW’s pioneering work has led to the regulatory approval of world first, potentially life improving, cannabis-based medicines. Our continued dedication has resulted in the treatment of thousands of patients with our medicines around the world. For further information, please visit www.gwpharm.co.uk

About EPIDIOLEX®/EPIDYOLEX® (cannabidiol)
EPIDIOLEX®/EPIDYOLEX® (cannabidiol), the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. and the European Commission (EC) for use in Europe, is an oral solution which contains highly purified cannabidiol (CBD). In the U.S., EPIDIOLEX® is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome or Tuberous Sclerosis Complex (TSC) in patients one year of age and older. EPIDIOLEX® has received approval in the European Union under the tradename EPIDYOLEX® for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and Dravet syndrome in patients two years and older. EPIDIOLEX/EPIDYOLEX® has received Orphan Drug Designation from the FDA and the EMA for the treatment of seizures associated with Dravet syndrome, LGS and TSC, each of which are severe childhood-onset, drug-resistant syndromes.

About Chiesi Australia

Chiesi Australia is the Australia-New Zealand division of the Chiesi Group, a global pharmaceutical company based in Parma, Italy. The Chiesi Group acquired Emerge Health in November 2019. The Chiesi Group (also known as Chiesi Farmaceutica) is an international research focused Group with over 80 years’ experience in healthcare, operating in 29 countries. The Group conducts research, develops treatment options and supplies innovative drugs to treat a wide range of conditions. The Group’s Research and Development Centre is based in Parma, Italy and coordinates the activities of four important R&D groups in France, USA, UK and Sweden to drive its own pre-clinical, clinical and registration programs. The Group continues to focus in areas of respiratory diseases, specialty care and rare diseases.

1. Bourgeois, B. F., Douglass, L. M. and Sankar, R. (2014), Lennox‐Gastaut syndrome: A consensus approach to differential diagnosis. Epilepsia, 55: 4-9. Doi:10.1111/epi.12567.

2. Arzimanoglou A, French J, Blume WT, et al. Lennox-Gastaut syndrome: a consensus approach on diagnosis, assessment, management, and trial methodology. Lancet Neurol. 2009;8(1):82-93.

3. Dravet C. The core Dravet syndrome phenotype. Epilepsia. 2011;52 Suppl 2:3-9.