The U.S. Food and Drug Administration (FDA) has approved U.S. sales of a drug derived from marijuana plants, U.K.-based GW Pharmaceuticals PLC (NASDAQ: GWPH) announced Monday. The FDA has okayed the sale of Epidiolex to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years old or older.
The prescription formulation of Epidiolex is a highly purified cannabidiol (CBD) derived from the marijuana plant but lacking the psychoactive ingredient most people associate with marijuana. The drug also is being reviewed for sale in Europe and a decision on that review is due in the first quarter of next year.
GW also manufactures a cannabis plant-derived drug to treat spasticity associated with multiple sclerosis, but the drug, called Sativex, is not approved for sale in the United States. The company is planning a U.S. Phase 3 trial of the drug, along with Phase 1 and 2 trials of compounds to treat epilepsy, glioblastoma and schizophrenia.
GW’s CEO Justin Gover said:
Today’s approval of EPIDIOLEX is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies. 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.
There is one remaining wrinkle, however:
As part of the approval process, EPIDIOLEX must be rescheduled from its current Schedule I before it can be made available to patients. Rescheduling is expected to occur within 90 days. Access is expected to be similar to other branded [anti-epilepsy drugs] and EPIDIOLEX is expected to be available to appropriate patients by Fall 2018.
Epidiolex will be marketed in the United States by GW’s U.S. subsidiary, Greenwich Biosciences.
GW’s American depositary shares (ADS) traded down about 3.8% Monday, at $145.45 in a 52-week range of $95.65 to $164.76. The 12-month price target is $179.20. One ADS is equal to 12 ordinary shares.