- A Food and Drug Administration Advisory Committee voted 13-0 on Thursday that the benefit/risk profile of GW Pharmaceuticals plc's Epidiolex, potentially the first marijuana plant-derived drug, was favorable to treat seizures in patients with Lennox-Gastaut syndrome and Dravet Syndrome ages two years and older.
- The FDA is not required to follow the advice of its panels, but usually does. A decision is expected by June 27. Analysts from Cowen expect no obstacles to the approval of Epidiolex. "There would seem to be little risk to Epidiolex's approval on (or likely before) its June PDUFA," they wrote in a note to investors, projecting sales of the drug to reach $1.1 billion by 2022.
- During the panel meeting on Thursday morning, FDA regulators focused on whether Epidiolex causes enzyme elevations characteristic of liver toxicity — but ultimately deemed the management of these risks could be straightforward with proper communication and labeling.
Now that GW Pharma has faced its first regulatory hurdle — and looks set to garner an FDA OK — the next major obstacle will be scheduling of the drug by the Drug Enforcement Administration.
Though the abuse potential of Epiodiolex was determined to be negligible, briefings docs noted there was some evidence of residual THC found in the drug used in the trials. The varying levels of leftover THC that were observed would be something the DEA would consider in an assessment of the drug's potential for abuse should the drug win approval, Barbara Carreno, a DEA spokesperson, confirmed to BioPharma Dive.
The DEA works in tandem with FDA, according to Carreno. "If the FDA approves CBD and Epidiolex for epilepsy, then yes, that would be rescheduled to one of the medical schedules [Schedule 2-5]."
"FDA sends us a request for scheduling, and they will often recommend what schedule they think it should go into — but we are not bound by that," Carreno said. "In this case, if FDA approves this and sends over a request that we schedule it ... we are bound by the science provided to us by [the Department of Health and Human Services], whether it's FDA, [National Institute on Drug Abuse], whoever — all that science would come over to us and we would use that science to determine which schedule to put it in."
Cowen analysts seemed confident about a reclassification and said that GW’s candidate will be launched in September "following a 90-day period during which DEA will reschedule Epidiolex."
Ahead of a potential launch, GW is working to highlight the various differences between its product and other cannabis-based products, noting that Epidiolex would be tested to ensure it contains "consistent concentrations of cannabinoids and other product ingredients listed on the label."
In addition, GW has said FDA-approved CBD-based products would only be available at specialty or retail pharmacies, not dispensaries.