Epilepsia, 55: 4-9. Offsetting this, it had US$477.6m in cash and US$80.4m in receivables that were due within 12 months. 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. “We are delighted to announce the TGA registration of EPIDYOLEX®, an important step forward for the management of LGS and Dravet syndrome. For further information, please visit www.gwpharm.co.uk. “This marks our third global regulatory approval and is another important step for GW and the patients we are here to support. Turn Customers into Fans, 3 Things to Look for In an IoT Connectivity Provider, Self-Service Maturity Model: Gaining a Competitive Advantage from Self-Service, Why You Need to Embrace Conversational AI for Customer Care, Buyers Guide to Intelligent Virtual Agents and Chatbots, 4 SIMPLE STEPS FOR DEPLOYING IoT: MANAGING THE ECOSYSTEM, Michael Trace / Ben Atwell, FTI Consulting, Stephen Schultz, VP Investor Relations, GW. “We are delighted to announce the TGA registration of EPIDYOLEX®, an important step forward for the management of LGS and Dravet syndrome. 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). 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. Epilepsia. 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 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. Many patients with LGS or Dravet syndrome have multiple seizures per day, which puts them at ongoing risk of falls and injury. This area is dedicated to keeping shareholders and potential investors up to date with share price, news … Many patients with LGS or Dravet syndrome have multiple seizures per day, which puts them at ongoing risk of falls and injury. Our continued dedication has resulted in the treatment of thousands of patients with our medicines around the world. All rights reserved | Privacy Policy, Ultra-Broadband PMR: 5 business models for enhanced mission critical operations, Dynamic Assurance For Network And Service Event Manager, Seizing the Moments: The Insider's Guide to Perfecting the Customer Journey, Changing the User Experience with HD Voice, Phone.com Transforms Small Businesses Using VoIP and the Cloud, eBook: The Power of Emotion in Customer Service, eBook: The Innovator's Guide to the Digital-First Contact Center, Checklist: Power of Emotion. 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. 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.