GW Pharmaceuticals PLC (NASDAQ: GWPH) shares were relatively muted on Thursday following a meeting by the U.S. Food and Drug Administration (FDA). As it turns out, GW Pharma won an FDA recommendation for its cannabis drug. Although this comes as no real surprise as most investors priced in this move back on Tuesday.
The Peripheral and Central Nervous System Drugs Advisory Committee of the FDA voted unanimously to recommend supporting the approval of the New Drug Application (NDA) for its cannabis drug that works to treat childhood epilepsy.
Evidence showed that Epidiolex, GW Pharma’s lead cannabinoid product candidate and a proprietary oral solution of pure plant-derived cannabidiol (CBD), effectively combated epilepsy.
Many believed that being cannabis-derived would be an obstacle to Epidiolex’s regulatory approval, but that doesn’t seem to be the case. The FDA briefing did not raise any issues regarding the CBD, citing that it “has a negligible abuse potential.”
It’s worth pointing out that this could very well be the first cannabis-derived drug approved in the United States. Traditionally, the FDA follows the recommendation of its advisory committees, though it is not bound to do so.
According to the briefing document, the FDA drew the conclusion that:
The safety and tolerability profile of CBD-OS is predictable, and the potential risks are manageable through the proposed label and medication guide …
Overall, CBD-OS provides a positive benefit-risk for patients with drug-resistant Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) and can satisfy an unmet need by providing an additional treatment option to reduce the number of seizures in LGS and the first indicated treatment option for DS.
Shares of GW Pharma were last seen at $133.39, with a consensus analyst price target of $151.29 and a 52-week range of $92.65 to $143.37.