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"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."


F.D.A. Peripheral and Central Nervous System Drug Advisory Committee hearing on Epidiolex

On April 19, 2018, Epilepsy Foundation President & CEO Phil Gattone testified before the U.S. Food & Drug Administration (FDA) Peripheral and Central Nervous System Drug (PCNS) Advisory Committee in support of the approval of Epidiolex for the treatment of Dravet and Lennox-Gastaut syndromes. Phil was joined by Polly VanderWoude, the mother of Olivia, who has been part of the Epidiolex clinical trials under the care of Dr. Orrin Devinski. Polly shared with the committee Olivia’s journey before and after Epidiolex and how the medication has allowed her daughter to experience seizure free days and an improved quality of life. Many other families shared stories similar to Olivia’s during the open public hearing portion of the meeting. Also in attendance was EF Professional Advisory Board member, Dr. Barbara Kroner with her daughter Ellie, who has also been part of the clinical trial.

The Advisory Committee voted unanimously (13 -0) in support of approval of Epidiolex. This follows the recommendation by staff that Epidiolex be approved. A decision by FDA is expected by June 27. We issued a statement applauding the Advisory Committee’s action and several news outlets picked up the story (MedPage Today, CNN, NBC News and Washington Post).

Epidiolex represents hope for the many individuals living with intractable seizures and rare epilepsies. The Epilepsy Foundation will continue to advocate for changes in state laws required to ensure a state pathway for timely access to Epidiolex once approved by FDA. Many have joined us on this effort which has been underway since 2016.

Authored By Beatriz Duque Long, Senior Director Government Relations, Epilepsy Foundation