UPDATE: GW Pharma gets EU approval for cannabis-based drug as treatment for severe childhood epilepsy

GW Pharmaceuticals PLC shares rose 3.9% in premarket trade Monday, after the company said it has received European Commission approval for its cannabis-based drug Epidyolex for the treatment of seizures in patients with Lennox-Gastaut syndrome or Dravet syndrome, in conjunction with clobazam, two severe types of childhood epilepsy. The drug, which is already approved in the U.S. under the brand name Epidiolex, will now be available to children of 2 years of age and older across Europe. The news "marks a significant milestone, offering patients 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 statement. The approval is based on the results from four randomised, controlled phase 3 trials, involving more than 714 patients. GW Pharma shares have gained 32% in 2019, while the S&P 500 has gained 19%.

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