The European Commission gave Epidyolex the green light after it was satisfied by the results of a clinical trial featuring more than 700 patients. It is used to treat two forms of severe childhood epilepsy, Lennox‑Gastaut syndrome and Dravet syndrome, which are both resistant to treatment.
Last year, it became the first cannabis-based medicine to secure FDA approval, allowing doctors in the U.S. to prescribe it for children aged two or older. It is registered as Epidiolex in the U.S.
Now it has become the first cannabis-based medicine to gain EU approval, a decision that should pave the way for doctors across the continent to prescribe it. Europe is on course to become the world’s largest medicinal cannabis market in the next few years, and the ruling should help GW Pharma become a major player.
Campaigners welcomed the news. “The approval of cannabidiol oral solution is an important milestone for patients and families whose lives are significantly impacted by these rare, complex and life-long forms of epilepsy,” said Isabella Brambilla, chairman at the Dravet Syndrome European Federation.
Academics specializing in epilepsy from across Europe also praised the commission’s decision.
Epidiolex achieved net sales of $68.4 million in the U.S. during Q2 2019, taking half-year net sales to $101.9 million. More than 12,000 patients have received Epidiolex prescriptions since it was approved, and over 2,500 physicians have prescribed it.
The plan is to launch in France, Germany, and the UK before the end of the year, with Spain and Italy following in 2020.
GW Pharma achieved overall net revenue of $72 million and other income of $104 million in Q2, resulting in a net income of $79.7 million for the quarter. Cash and cash equivalents for on June 30, 2019, was $583.7 million.
GW Pharma was trading at $101.01 at the start of 2019. It reached $187.21 in May, before decreasing to $128.92 when trading closed on Friday. It then opened at $133.50 this morning.
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