CBD Oil Gains Approval In Europe — But Biotech Gives Back Early Gains
GW Pharmaceuticals stock initially popped, then toppled, Monday after European regulators approved the biotech company’s CBD oil in two seizure disorders.
Cannabidiol, the long-winded name for CBD, is an active ingredient in cannabis. GW Pharmaceuticals‘ (GWPH) Epidyolex is the first CBD oil derived directly from the cannabis plant to gain approval in Europe. Its counterpart, Epidiolex, was the first CBD oil to gain approval in the U.S. in 2018.
Epidyolex was approved in conjunction with another drug, clobazam, to treat seizures associated with Lennox Gastaut and Dravet syndromes. Both are forms of epilepsy that begin in childhood. Now, the biotech company plans to launch Epidyolex across Europe.
“The approval of Epidyolex marks a significant milestone, offering parents and their families the first in a new class of epilepsy medicines and the first and only EMA-approved CBD medicine to treat two severe and life-threatening forms of childhood-onset epilepsy,” Chief Executive Justin Gover said in a written statement.
CBD Oil Gains Approval In Europe
The approval stems from four Phase 3 studies of 714 patients, GW said in a news release. When added to other anti-epileptic therapies, Epidyolex significantly reduced the frequency of seizures in patients with Lennox Gastaut or Dravet syndromes.
Common side effects included sleepiness, decreased appetite, diarrhea, fever, fatigue and vomiting.
GW Pharmaceuticals is looking to expand its success with Epidiolex in the U.S. In the second quarter, Epidiolex sales were $72 million, well above expectations for $47 million. Last month, the biotech company noted more than 12,000 patients had received the CBD oil since its 2018 launch.
The approval of Epidyolex in Europe comes a month ahead of GW’s expectations. In August, the biotech company said it expected first to launch in France, Germany and the U.K., with Spain and Italy to follow in 2020.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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