NCBiotech-Nurtured UK Company Gets Landmark FDA OK for Seizure Drug Derived from Marijuana

A British company with U.S. headquarters in Research Triangle Park has become the first to receive U.S. Food and Drug Administration approval for a prescription drug derived from marijuana.

London-based GW Pharmaceuticals and its U.S. subsidiary, Greenwich Biosciences, have spent years developing novel therapeutics from their cannabinoid product platform. Now, the FDA has approved EPIDIOLEX (cannabidiol or CBD) as an oral treatment for seizures associated with two rare, severe forms of epilepsy that are notoriously treatment resistant.

Though it’s a marijuana derivative, the active ingredient in EPIDIOLEX does not have the mind-altering capabilities of marijuana. It does, however, treat Lennox-Gastaut syndrome (LGS) or Dravet syndrome.

Those syndromes can develop in childhood, and most patients with LGS or Dravet require multiple seizure medications. The majority are resistant to currently approved therapies. The day-to-day impact of these conditions is significant, with high rates of early mortality, GW said announcing FDA approval of its treatment.

Justin Gover, GW’s CEO, said in a statement, “This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much-needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

“LGS and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy. These children and their families face a long and challenging road and very few achieve adequate seizure control,” said Elizabeth Thiele, M.D., director of the pediatric epilepsy program at Massachusetts General Hospital, professor of neurology at Harvard Medical School and a lead investigator in the EPIDIOLEX clinical program.

“Based on numerous clinical trials, this medication may help meet the need for this specific pediatric patient population and is now the first to be approved by the FDA in Dravet syndrome.”

GW was co-founded in 1998 by Geoffrey Guy, Dip Pharm Med, and Brian Whittle, Ph.D., two well-known entrepreneurs in the UK biotech sector. It previously developed Sativex, to treat spasticity due to multiple sclerosis. It’s sold in 27 countries outside the United States, and is also in Phase 3 clinical development as a potential treatment of pain associated with advanced cancer.

Greenwich will market EPIDIOLEX in the U.S. The North Carolina Biotechnology Center worked with GW to open its first U.S. office in RTP as one of the early tenants of the Biotech Center’s Landing Pad company recruitment program.

“While here,” said Biotech Center President and CEO Doug Edgeton, “GW accessed almost all the resources the Center has to offer and it was a true team effort.”

GW, he noted, “Is part of the growing list of successful Biotech Center Landing Pad alumni."

The Greenwich website offers a “Spotlight” Q&A with Ben Whalley, its director of research, on the science behind cannabinoids.