GW Pharma's cannabis-derived epilepsy medicine makes the cut in the European Union
GW Pharma’s cannabis-derived medicine for epilepsy has won European endorsement, more than a year after the British drugmaker secured its landmark US approval.
The medicine, christened Epidyolex in the EU, is a plant-derived formulation of cannabidiol (CBD). It was approved in June by the US authorities and launched in the region in November. The London-based company generated nearly $102 million selling the drug in the first half of this year — and has treated over 12,000 patients in the United States.
On Monday, GW $GWPH said the drug had been sanctioned for use in patients with either Lennox‑Gastaut syndrome (LGS) or Dravet syndrome — two rare, and notoriously hard-to-treat forms of childhood-onset epilepsy characterized by persistent seizures — in conjunction with clobazam. The European Medicines Agency has approved the drug for use across the European Union, alongside Norway, Iceland, and Liechtenstein.
Cantor Fitzgerald’s Elemer Piros expects GW to generate $53 million in European sales next year, and anticipates the drug will rake in close to $500 million in 2025, with a peak market penetration of 30%, he wrote in a note on Monday.
In the United Kingdom, a concerted campaign to unlock the use of cannabis to treat severe childhood epilepsy prompted the British authorities last year to sanction its use in certain patients, when other medicines have failed, after consultation with a specialist doctor.
However, last month NHS England and cost-effectiveness watchdog NICE issued a statement suggesting the research on the use of cannabis (or its derivatives) was not compelling enough to justify its medical use, citing the lack of randomized control trial (RCT) as a major hurdle to prescribing among other concerns. NICE also failed to back the use of GW’s drug — although negotiations between the two are ongoing.
The historic FDA approval of GW Pharma’s cannabis drug earlier this year paved the way for a plethora of small and mid-sized drug developers — including Zynerba $ZYNE, InMed Pharma, Kannalife and Axim Biotech $AXIM who are either developing synthetic or natural cannabis-derived therapeutics or devising novel delivery mechanisms for its absorption, to treat a plethora of medical conditions.
Even big pharma now has its paws in the burgeoning field — Swiss giant Novartis’ $NVS Sandoz AG unit has tied up with Canadian medical cannabis producer Tilray and medical cannabis grower Canndoc has tied up with Teva’s $TEVA SLE group to distribute its medical cannabis products in Israel.
Social image: Shutterstock