6th Jun 2014 08:55
LONDON (Alliance News) - GW Pharmaceuticals PLC said Friday its Dravet syndrome treatment Epidiolex had been granted 'Fast Track' status by the US Food and Drug Administration.
This status is intended to speed up the reviewing process of certain drugs that treat serious conditions or fill an unmet medical need, and can receive a five-year extension to market exclusivity on approval.
Dravet syndrome, also known as Severe Myoclonic Epilepsy of Infancy, is a rare form of epilepsy that develops within the first year, and presently does not have a cure.
The treatment has already received an orphan drug designation for Dravet, as well as for Lennox-Gastaut syndrome, another rare form of childhood epilepsy.
The orphan drug qualification means that the product has been designed specifically to tackle a rare disease that affects a small percentage of the population. This designation means that developers are entitled to a seven-year exclusive marketing period in the US for the product.
GW Pharmaceuticals said it is on track to begin a phase 2/3 clinical trial of the treatment in the second half of the year.
Shares in GW were trading up 3.6% at 350.18 pence Friday morning.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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