GW Pharmaceuticals plc and its U.S. Subsidiary Greenwich Biosciences Announce FDA Approval of EPIDIOLEX® (cannabidiol) oral solution – the First Plant-derived Cannabinoid Prescription Medicine
“Today’s approval of EPIDIOLEX is a historic milestone, offering patients and their families the first and only
LGS and Dravet syndrome, which develop in childhood, are rare, severe forms of epilepsy that are notoriously treatment-resistant.1,2 Most patients with LGS and Dravet syndrome require multiple seizure medications and the majority are resistant to currently approved AEDs.2,3,4 The day-to-day impact of these conditions is significant with high rates of early mortality.5,6
“In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD,” said
“LGS and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy. These children and their families face a long and challenging road and very few achieve adequate seizure control,” said
The EPIDIOLEX clinical development program included three randomized, controlled Phase 3 clinical trials and an open-label extension study. In the Phase 3 studies, published in
“For those living with intractable seizures caused by LGS and Dravet syndrome, EPIDIOLEX represents a true medical advancement,” said
EPIDIOLEX will be marketed in the U.S. by Greenwich Biosciences, the U.S. subsidiary of
Outside the U.S., this medicine is currently under review by the
For more information on Dravet syndrome and Lennox-Gastaut syndrome, including community support, please visit the
About EPIDIOLEX® (cannabidiol) oral solution
EPIDIOLEX, the first prescription, plant-derived cannabinoid medicine in
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW, along with its U.S. subsidiary Greenwich Biosciences, has received U.S.
This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the relevance of GW products commercially available and in development, the clinical benefits of EPIDIOLEX (cannabidiol) oral solution and the safety profile and commercial potential of EPIDIOLEX. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, and the acceptance of Sativex, EPIDIOLEX and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW’s filings with the
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2 Dravet C. The core Dravet syndrome phenotype. Epilepsia. 2011;52(Suppl. 2):3–9.
5 Cooper MS, Mcintosh A, Crompton DE, et al. Mortality in Dravet syndrome. Epilepsy Res. 2016;128:43-47.
6 Trevathan, E. Infantile Spasms and Lennox-Gastaut Syndrome. Journal of child neurology 17, 2S9-2S22 (2002).
7 Devinsky O, Cross JH, Laux L, et al. Trial of cannabidiol for drug-resistant seizures in the Dravet syndrome. N Engl J Med 2017;376;2011-20.
8 Devinsky O, Patel AD, Cross JH, et al. Effect of Cannabidiol on Drop Seizures in the Lennox–Gastaut Syndrome. N Engl J Med 2018;378;20:1888-97.
9 Thiele EA, Marsh ED, French JA, et al. Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomized, double-blind placebo-controlled phase 3 trial. Published online
Source: GW Pharmaceuticals plc