LANDOVER, MD, June 25, 2018 — We are pleased about the U.S. Food & Drug Administration’s (FDA) decision to approve EPIDIOLEX® (cannabidiol) oral solution for the treatment of seizures associated with two epilepsy syndromes known as Lennox-Gastaut syndrome and Dravet syndrome in patients two years of age or older. For those living with intractable seizures caused by Lennox-Gastaut syndrome and Dravet syndrome, EPIDIOLEX represents a true medical advancement. Clinical development for these rare and severe conditions is essential, and today’s news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures. The FDA approval of EPIDIOLEX will soon bring to market the first drug derived from cannabis plant in the U.S. for those currently living with Dravet syndrome and Lennox-Gastaut syndrome.
Dravet syndrome is a rare and catastrophic form of intractable epilepsy that begins in infancy and is highly treatment-resistant. It is a debilitating, life-long condition characterized by frequent and prolonged seizures, poor seizure control, and developmental delays, as well as an increased risk of premature death including sudden unexpected death in epilepsy (SUDEP). Lennox-Gastaut syndrome is a rare and often debilitating form of childhood-onset epilepsy that is highly treatment-resistant. It is characterized by multiple seizure types, and moderate to severe cognitive impairment. Individuals living with Lennox-Gastaut syndrome experience an increased risk of serious injury because of frequent falls associated with uncontrolled seizures.
Individuals with these epilepsy syndromes often experience uncontrolled seizures and other medical needs throughout their lifetime. Therapies derived from cannabidiol show promise for patients with Dravet syndrome, Lennox-Gastaut syndrome and several other rare epilepsies, such as Tuberous Sclerosis Complex, and Infantile Spasms.
As the leading national health organization speaking on behalf of the 3.4 million in the U.S. with epilepsy and seizures, the Epilepsy Foundation actively advocates for more and better epilepsy treatments. In addition, under the leadership of Warren Lammert, former Board Chair and parent of a child with Dravet syndrome, the Epilepsy Foundation's Epilepsy Therapy Project invested in research on cannabidiol for epilepsy.
When a person has two unprovoked seizures or one unprovoked seizure with the likelihood of more, they are considered to have epilepsy. (An unprovoked seizure is one that occurs for no known reason.) Epilepsy affects more than 3.4 million people in the U.S. and 65 million worldwide. This year, another 150,000 people will be diagnosed with epilepsy. Despite all available treatments, at least 3 out of 10 people with epilepsy continue to experience uncontrolled seizures while many more experience less than optimal seizure control.
About the Epilepsy Foundation
The Epilepsy Foundation, a national non-profit with over 50 local organizations throughout the U.S., has led the fight against seizures since 1968. The Foundation is an unwavering ally for individuals and families impacted by epilepsy and seizures. The mission of the Epilepsy Foundation is: to lead the fight to overcome the challenges of living with epilepsy and to accelerate therapies to stop seizures, find cures, and save lives. The Foundation works to ensure that people with seizures have the opportunity to live their lives to their fullest potential. For additional information, please visit epilepsy.com.
"Like" the Epilepsy Foundation on Facebook at facebook.com/epilepsyfoundationofamerica and follow us on Twitter at twitter.com/epilepsyfdn.