The European Commission approved GW Pharmaceuticals (NASDAQ: GWPH) to sell its star medication Epidyolex in the European Union (EU). The firm announced that Epidyolex has been permitted by the Commission, the EU pharmaceutical regulator, to help treat seizures in kids suffering from one of two types of epilepsy.
The drug, known in the U.S. as Epidiolex, was endorsed by the U.S. Administration of Food and Drugs in June 2018. In the first half of this year, it has become a hot commodity for the business, bringing in nearly $102 million in net revenues. It also helped significantly decrease the company’s operating loss.
An individual in a lab coat holding a cannabis leaf and cannabis oil and a bud around his throat with a stethoscope.
According to the company, Epidiolex was prescribed by more than 2,500 doctors and received by more than 12,000 patients. The company says it tends to stay on treatment for its patients.
Epidiolex is the first cannabidiol (CBD)-based FDA-approved drug, the substance found in cannabis that does not have a high user (which would be tetrahydrocannabinol or THC). GW Pharmaceuticals is therefore regarded to be a stock of marijuana.
The firm wrote in the press release announcing the news that “[ t]his approval is the culmination of many years of devotion and cooperation between GW, doctors and the community of epilepsy. We think that patients and doctors deserve access to rigorously tested and assessed cannabis-based medications, produced to the highest norms and approved by medicine regulators.”
The nod of the regulator provides the green light to GW Pharmaceuticals for marketing and selling Epidyolex in all 28 EU nations, plus Norway, Iceland, and small Liechtenstein. Initially, it will roll out the drug in France, Germany, and possibly the UK, followed by Spain and Italy in 2020. The company is estimating that the total EU market for Epidyolex is rough “a quarter to a third” of its U.