Cambridge seizures treatment closer to receiving European approval
Cambridge life science business GW Pharmaceuticals is on the verge of winning a key approval to roll out a cannabis-based medicine designed to treat certain seizures in Europe.
The European Medicines Agency’s 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 for patients aged two and older.
TSC causes mostly benign tumours to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys and lungs and epilepsy is the most common neurological feature. TSC is typically diagnosed in childhood.
The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 27 countries of the European Union alongside Norway, Iceland and Liechtenstein.
The EC is expected to make a final decision on the Type II Variation Application in approximately two months. If approved by the EC, the label for EPIDYOLEX® will expand to include a third indication in Europe.
Justin Gover, GW’s CEO, said: “Epilepsy is reported in more than 90 per cent of individuals with TSC and over 60 per cent of those with seizures associated with TSC do not respond to standard anti-epileptic medicines.
“The positive CHMP opinion brings us one step closer to a potentially life-improving new treatment option for these patients for whom EPIDYOLEX may be appropriate.”