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GW Pharmaceuticals plc (London, UK and Carlsbad, California) announced the financial results for the last quarter of 2018, which included two months of sales for Epidiolex. Epidiolex is the first plant-derived cannabinoid pharmaceutical ever approved by the U.S. Food and Drug Administration (FDA) and first ever approved medicine in the U.S. for Dravet syndrome.
According to the company, the net sales for Epidiolex during the November 1–December 31 launch period was $4.7 million, with approximately 4500 new patient enrollment forms in the first two month selling period. The company also reports that more than 500 physicians generated dispensed prescriptions during the first two months and the filled prescription growth trend in January 2019 showed 150% growth compared to December 2018.
“We are pleased by the high level of physician and patient demand for Epidiolex, and by the number of payors that have already made favorable coverage determinations for the product. With US launch taking place part way through the quarter, the two month selling period at the end of 2018 was primarily aimed at setting the commercial wheels in motion for the 2019 launch year. As we move into the new year, prescription growth trajectory has been highly encouraging and we believe that we are on track to deliver a successful market introduction of this important new treatment,” stated Justin Gover, GW’s Chief Executive Officer. “In addition to the US launch, we look forward to a positive regulatory decision in Europe in the next few months, results of a Phase 3 trial in tuberous sclerosis complex, and a number of advances in the pipeline.”
In addition, GW reports that their European submission is under review by the European Medicines Agency (EMA) with a recommendation from The Committee for Medicinal Products for Human Use (CHMP) expected in the second quarter of 2019.