FDA Approves GW Pharma's Epidiolex

28 June, 2018, 11:22 | Author: Lynne Higgins
  • FDA approves first ever drug derived from marijuana | TheHill

GW Pharmaceuticals' Epidiolex has become the first cannabinoid prescription medicine to be approved in the United States, winning clearance to treat two rare forms of epilepsy.

Billy Dunn, M.D., director of the Division of Neurology Products at the FDA's Center for Drug Evaluation and Research, said: "The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life". It's a CBD oil used to treat two rare types of epilepsy most often found in children.

FDA commissioner Scott Gottlieb has said that it is committed to this kind of careful scientific research and drug development making these kinds of important medical advances. Outside the US, this medicine is now under review by the European Medicines Agency (EMA) for the treatment of seizures associated with Dravet Syndrome and LGS.

Cannabidiol (CBD) is one of the most abundant compounds in the marijuana plant.

Most patients with LGS and Dravet require several drugs and are resistant to many now approved epilepsy drugs. As it stands, the article offers no information at all about reduction in seizures of those who take the drug, or a basis for which to compare its value to other treatments for severe epilepsy. The FDA noted in its announcement today that it informs and advises the DEA about scheduled substances. Common side effects include sleepiness, elevated liver enzymes, decreased appetite, diarrhea, rash, and weakness.

GW is also developing Epidiolex in tuberous sclerosis, and if approved in the third indication, sales could break through the billion dollar annual sales barrier.

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The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV. The company has not yet set a price for the drug and said it would work with insurance providers to ensure the medicine would be covered under health plans.

Justin Gover, CEO of GW Pharmaceuticals, the UK-based company behind the drug, said the approval signals "validation of the science of cannabinoid medication". Indeed, the FDA has been trying to crack down on CBD producers who make claims that their products can cure diseases like cancer.

As part of the approval process, EPIDIOLEX must be rescheduled from its current Schedule I before it can be made available to patients.

"It's time that we start taking a look at the marijuana plant, the cannabis derivative, and trying to find medical uses for it", he said to Maria Bartiromo on "Mornings with Maria". Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.

In order to obtain FDA approval for this specific drug targeting two particular medical conditions, GW Research Ltd. evaluated Epidiolex's efficacy and safety in three randomized, double-blind, placebo-controlled clinical trials.



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