GW Pharmaceuticals plc (London, UK and Carlsbad, California) recently announced the company’s financial results from the second quarter of 2019. The top points highlighted by the company were that U.S. net sales of Epidiolex were $68.4 million and the positive opinion from European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on EPIDYOLEX clears the way for an expected European approval in October 2019.
“We are pleased to report a strong second quarter of sales of Epidiolex in the U.S., reflecting high demand by U.S. patients, increased prescribing by healthcare providers, and ongoing progress in payor coverage determinations. With the recent positive Phase 3 trial in Tuberous Sclerosis Complex [TSC], we expect to submit an sNDA [supplemental new drug application] by the end of 2019 with the goal of expanding the Epidiolex label and market opportunity to include both children and adult patients with TSC, a highly treatment-resistant condition,” stated Justin Gover, GW’s Chief Executive Officer.
According to the company, more than 12,000 patients have received Epidiolex prescriptions since launch and more than 2500 physicians have generated dispensed prescriptions since launch. The company also states that the vast majority of patients who have received Epdiolex remain on therapy.
“In Europe, we are pleased to have recently received the positive opinion from the CHMP which clears the way for an expected approval in October. Our European commercial organization is in place and will be ready to launch in the first European markets upon approval, making this important new treatment option available to deserving European patients,” said Gover.
The European-version of the drug (called EPIDYOLEX) will be used as adjunctive therapy of seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older. GW Pharmaceuticals expects a fourth quarter launch in France, Germany, and UK with Spain and Italy launches to follow in 2020.