GW has established a world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise.
GW has developed an oral formulation of purified cannabidiol (CBD), initially approved as EPIDIOLEX® in the U.S. by the U.S. Food and Drug Administration (FDA). We initially launched EPIDIOLEX in the U.S. in November 2018 for the treatment for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients 2 years of age and older, two rare and severe early-onset, drug-resistant epilepsy syndromes. In July 2020, the FDA expanded the approval of Epidiolex, adding a new indication of seizures associated with Tuberous Sclerosis Complex or TSC in patients one year of age and older. Along with this new indication, the age range was expanded to include patients one year of age and older who experience seizures associated with LGS or Dravet syndrome. TSC is a rare disease that causes benign tumors to grow in vital organs of the body and is a leading cause of genetic epilepsy. This is the first cannabis plant-derived medicine ever approved by the FDA and has been descheduled by the U.S. DEA. The medicine was launched in the US as a prescription medicine by our US operating subsidiary, Greenwich Biosciences Inc., on November 1, 2018. This product has received approval in the EU by the European Medicines Agency (EMA) under the tradename EPIDYOLEX® for use as adjunctive therapy of seizures associated with LGS or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older.* EPIDYOLEX is currently under review by the EMA for seizures associated with TSC.
GW successfully developed the world’s first prescription medicine derived from the cannabis plant called Sativex® (nabiximols) in Europe, a formulated cannabis extract that contains the principal cannabinoids delta-9-tetrahydrocannibinol (THC) and cannabidiol (CBD), as well as other minor cannabinoids and terpenes, which is now approved in numerous countries outside of the US for the treatment of spasticity due to multiple sclerosis. GW continues to research and develop nabiximols and is commencing separate clinical programs in the United States for spasticity due to multiple sclerosis and spinal cord injury and for Post-Traumatic Stress Disorder (PTSD).
The company has a deep pipeline of additional clinical stage cannabinoid product candidates under development for both orphan and non-orphan indications with a particular focus on neurological conditions.
*See SmPC for full prescribing & safety information.