CARLSBAD, Calif. – Greenwich Biosciences, Inc. and its parent company GW Pharmaceuticals, a British company involved in the development and manufacturing of plant-derived cannabinoid therapy, announced Monday that its prescription medication Epidiolex has received approval from the U.S. Food and Drug Administration (FDA) for use in the treatment of seizures associated with tuberous sclerosis complex (TSC).
Initially approved by the FDA in June 2018 to treat seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome, Epidiolex holds the distinction of being the first FDA-approved drug derived completely from a cannabis plant. THC-free, it’s just the second FDA approval for a medical treatment of sclerosis-related seizures.
“FDA approval of this new indication is exciting news for those with refractory seizures due to tuberous sclerosis complex,” said GW Chief Executive Officer Justin Gover. “Since Epidiolex is already available to patients by physician’s prescription, patients with TSC can immediately access the medication. This label expansion, including the expansion of the age range in all approved indications, further demonstrates that the FDA process can continue to enable broader patient access to appropriately tested, regulatory approved cannabinoid medicines. It also provides hope for these patients and their families and is yet another important milestone for Epidiolex as a first-in-class antiepileptic drug.”
FDA approval includes a recommended maintenance dose of 25mg per day for sclerosis patients. The oral cannabidiol drug can be prescribed for patients as young as one year of age, a year younger than previously allowed.
“FDA approval of Epidiolex in TSC is a tremendous step forward and our community applauds this positive development,” said Kari Luther Rosbeck, president and chief executive officer for the Tuberous Sclerosis Alliance. “One of the most challenging and frustrating aspects of TSC are seizures that cannot be effectively controlled by existing medications. New treatment options are desperately needed, and this approval adds another option for those impacted by this difficult disease.”
In a sixteen-week trial, Epidiolex showed immense potential to relieve the seizure-stricken. The drug demonstrated its effectiveness when out of a pool of 224 patients, the 148 who were treated with it demonstrated fewer and less frequent seizures.
The drug’s side observed side effects ranged from diarrhea and decreased appetite, to vomiting, fever, and fatigue.
“Based on previous positive trial results in TSC patients, Epidiolex may become an important treatment option for patients,” said clinical investigator Elizabeth Thiele, director of the Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital and a professor of neurology at Harvard Medical School. “It is a new tool in the toolbox for physicians and could meet a significant unmet need.”
In anticipation of the successful trial and the latest FDA approval, GW Pharmaceuticals stock value has gained 22 percent year-to-date and analysts are confident the stock will continue its upward trajectory.
Francois Brisebois, an analyst at Oppenheimer, believes a $166 price point is within reach (the stock was around $135 on Tuesday).
“We see upside potential with large other refractory epileptics not currently accounted for,” Brisebois told Yahoo! Finance. “Our Outperform thesis is based on our view that the potential for Epidiolex use in multiple seizure types including those associated with tuberous sclerosis complex are not fully reflected in the stock at current levels.”