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GW Pharmaceuticals Epidiolex Gets Orphan Drug Designation From EMA

Wed, 22nd Oct 2014 07:47

LONDON (Alliance News) - GW Pharmaceuticals PLC said Wednesday that its investigational compound Epidiolex has been granted an orphan drug designation by the European Medicines Agency for the treatment of rare epilepsy form Dravet syndrome.

The company said it has also been granted a fast track designation by the US Food and Drug Administration for Dravet syndrome, as well as orphan designations for both Dravet syndrome and Lennox-Gastaut syndrome.

It said it will imminently begin full clinical development for Epidiolex for Dravet syndrome and LGS, with the first phase 2/3 clinical trial due to begin in "the coming weeks."

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.

"We believe that the clinical effect and safety data recently released on Epidiolex support GW's confidence in the prospect of ultimately enabling children with Dravet syndrome around the world to have access to an approved prescription cannabidiol medicine," said Chief Executive Justin Gover in a statement.

Shares in GW Pharmaceuticals are trading up 4.1% at 384.80 pence Wednesday morning.

By Hana Stewart-Smith;; @HanaSSAllNews

Copyright 2014 Alliance News Limited. All Rights Reserved.

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