GW Pharmaceuticals receives positive CHMP opinion for Epidyolex for use as treatment of seizures associated with tuberous sclerosis complex
GW Pharmaceuticals plc , a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines, announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Company’s Type II variation application for Epidyolex (cannabidiol) as an adjunctive treatment of seizures associated with Tuberous Sclerosis Complex (TSC), for patients two years of age and older.
TSC is a condition that causes mostly benign tumours to grow in vital organs of the body, including the brain, skin, heart, eyes, kidneys and lungs, and in which epilepsy is the most common neurological feature. TSC is typically diagnosed in childhood.
Professor Helen Cross, Honorary Consultant in Paediatric Neurology at Great Ormond Street Hospital for Children NHS Foundation Trust, said, “This debilitating disease affects tens of thousands of patients in Europe, many of whom may benefit from alternative treatment options to achieve adequate seizure control. This decision, and the clinical data supporting the use of Epidyolex in this challenging condition, offers real hope to the patients, their parents and physicians that battle this condition and the seizures it brings every day.”