FDA OKs new indication for Greenwich Biosciences' Epidiolex

Epidiolex, the first and only prescription CBD-based drug, has a new indication. 

The Food and Drug Administration has approved Greenwich Biosciences' Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with tuberous sclerosis complex, or TSC, in patients 1 year old and older. 

"Up to 85% of those affected by TSC experience seizures at some point in their lifetime," explained TS Alliance president and CEO Kari Luther Rosbeck. "Unfortunately, existing medications don't always effectively control them. Our organization and the TSC community certainly welcome a new option such as Epidiolex, which is the second FDA-approved drug specific to TSC."

This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.

"The FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions. This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients," said Douglas Throckmorton,  deputy center director for regulatory programs in the FDA's Center for Drug Evaluation and Research. "The agency is committed to supporting rigorous scientific research on the potential medical uses of cannabis-derived products and working with product developers who are interested in bringing patients safe and effective, high quality products."

Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.