GW Pharmaceuticals in Cambridge has won a key European approval for a cannabis-based drug to fight Dravets syndrome a rare and lethal form of childhood epilepsy resistant to current treatments.
Added to fast-track FDA approval for its solution, Epidolex, in the US this gives the UK business a battery of options in the fight for a global cure.
GWs CEO Justin Gover said the European Medicines Agency approval would accelerate the companys development programme.
He said: Dravet syndrome represents a very substantial unmet need in Europe and a significant therapeutic challenge as many of the children suffering with this condition are resistant to current treatments and have exhausted all options.
GW is now advancing a full clinical development programme for Epidiolex in Dravet syndrome and looks forward to starting this programme in the coming weeks.
We believe that the clinical effect and safety data recently released on Epidiolex support GWs confidence in the prospect of ultimately enabling children with Dravet syndrome around the world to have access to an approved prescription CBD medicine.
In addition to this orphan designation by the EMA, GW has been granted fast track designation by the US Food and Drug Administration for Epidiolex in the treatment of Dravet syndrome as well as orphan designations in both Dravet syndrome and Lennox-Gastaut syndrome another hard-to-treat form of childhood epilepsy.
GW is about to start a full clinical development programme for Epidiolex in the treatment of both Dravet syndrome and LGS, working with leading pediatric epilepsy specialists across the US. The first Phase 2/3 clinical trial is due to start in the coming weeks.
GW last week announced updated physician reports of Epidiolex treatment effect in children and young adults with treatment-resistant epilepsy. Of the 58 patients in this report, 12 had Dravet syndrome.
These patients reported a median overall reduction in convulsive seizure frequency of 51-72 per cent across a range of time points and analyses. The most common adverse events were somnolence and fatigue.
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Cambridge drug hope for lethal child epilepsy