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EC approval for CBD-based drug to treat two rare types of childhood epilepsy
Epidyolex’s manufacturers GW Pharma have announced the European Commission (EC) has approved the 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.
This approval, which represents the third indication for GW’s cannabidiol in Europe, paves the way for the expanded launch of the medicine across Europe.
Dr Volker Knappertz, GW’s Chief Medical Officer, said; “The clinical data supporting Epidyolex in TSC provides hope of a better quality of life for patients. This medicine provides more choice for physicians managing seizures associated with TSC and has the potential to benefit the thousands of patients who do not respond to the current standard of care.”
NorwayIcelandLiechtensteinVolker-knappertzEuropean-unionEuropean-medicines-agencyEuropean-commissionMedical-officerJustin-goverLennox-gastaut-syndromeநோர்வேஐஸ்லாந்துGW Pharma’s Epidyolex scores new EU indication
21st April 2021
GW Pharmaceuticals’ Epidyolex has received approval from the European Commission (EC) for the treatment of seizures associated with tuberous sclerosis complex (TSC) – its third indication in Europe.
Specifically, Epidyolex (cannabidiol) has been approved as an adjunctive treatment of seizures associated with TSC for patients aged two years and older.
TSC is a rare genetic condition that causes mostly benign tumours to grow in vital organs including the brain, skin, heart, eyes, kidney and lungs.
The condition is typically diagnosed in childhood and the most common neurological feature in TSC is epilepsy. It is also associated with an increased risk of autism and intellectual disability, although the severity of the condition can vary widely.
Volker-knappertzEuropean-commissionLennox-gastaut-syndromeGw-pharmaceuticalsPidyolexCannabidiolTuberous-sclerosis-complexஐரோப்பிய-தரகுக்வ்-மருந்துகள்