GW Pharma $GWPH finished its layup at the FDA today with Epidiolex, grabbing its first ever marketing OK for one of its cannabinoid drugs and setting up the biotech for a major shift toward commercialization.
Two months after a unanimous recommendation by an outside group of FDA experts and some glowing recommendations in the internal review, GW will now set out to open up a new class of meds after demonstrating the drug’s ability to prevent seizures in children suffering from rare cases of Lennox-Gastaut syndrome and Dravet syndrome.
The approval was recorded on the FDA’s website and word spread quickly through Twitter.
Clarivate has pegged 2022 sales at a blockbuster sized $1.2 billion, making this rollout a hugely important event for the UK-based company.
The FDA’s Scott Gottlieb did the honors in the statement today, celebrating GW for the work they did, and warning anyone else against trying to market cannabis-related products with dubious support for their claims.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said Gottlieb. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
GW CEO Justin Gover told the Financial Times over the weekend that it had taken “an awful long time to get to where we are . . . but we’ve really built a huge lead. We’re the world-leaders in cannabinoid science, and I think we expect to stay there for quite some time.”
From GW’s perspective this is just the beginning, with plans to pursue more research work in a variety of ailments.
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