FDA Staff Backs Drug Made From Cannabis Plant
An experimental medication that could become the first drug derived from a marijuana plant approved in the U.S. received a boost from Food and Drug Administration staff.
The treatment’s maker, U.K. company GW Pharmaceuticals Plc, provided “substantial evidence” of the drug’s effectiveness, FDA staff said in a report released Tuesday. The medication would treat seizures associated with two rare forms of epilepsy that typically affect children, according to the report. Although the medication appears to have an increased risk of liver injury, it could be managed, the report said.
“The risk-benefit profile established by the data in the application appears to support approval of cannabidiol,” FDA staff wrote.
GW Pharma’s American depositary receipts rose 4.5 percent to $126 in early trading in New York.
Later this week, a meeting of outside agency advisers will weigh in on the treatment.
The drug is made from a compound in the marijuana plant called cannabidiol, a different chemical from tetrahydrocannabinol, or THC, which gives marijuana its euphoric effect.
The treatment, which GW Pharma hopes to market under the name Epidiolex, is produced in the U.K. from a plant that has been bred to have a high cannabidiol, or CBD, content, Chief Executive Officer Justin Gover said in an interview earlier this month. The chemical is purified and made into a strawberry-flavored oral solution, he said.
Approval could help pave the way for other cannabis-based drugs, Gover said.
“Epidiolex, if approved, will mark a sea change in the acceptability of cannabinoids as therapy,” he said.
Twenty-nine states and Washington, D.C., have passed laws legalizing medical marijuana. FDA approval would provide patients with a consistent therapy that likely will be covered by insurance, Gover said.
The drug company is seeking to sell the oral solution to treat seizures associated with two forms of epilepsy, Lennox-Gastaut and Dravet syndromes, in patients aged 2 or older. Both are considered severe forms of epilepsy that begin in childhood. The syndromes are resistant to many treatments and as many as 20 percent of children with Dravet syndrome die before reaching adulthood, according to the National Institutes of Health.
The FDA has approved a few drugs made from synthetic cannabinoids, including Insys Therapeutics Inc.’s Syndros for loss of appetite in people with AIDS and nausea caused by chemotherapy. Insys is developing a cannabidiol oral solution for a severe type of epileptic seizure known as infantile spasms, and childhood epilepsy defined by staring spells where the child isn’t aware or responsive.
The FDA is expected to decide whether to approve GW Pharma’s drug by June 27. The agency will first discuss the drug with advisers on Thursday.
GW Pharma is studying the medication to treat other diseases, including infantile spasms.