GW Pharma Gets Fast-Track Designation for Epidiolex

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The FDA granted fast track designation to GW Pharmaceuticals’ (GWPH) Epidiolex for the treatment of children suffering from Dravet syndrome. Shares were up more than 6% on the news.

We note that the FDA grants fast-track designation to those candidates under development for the treatment of serious conditions, which have an unmet medical need, with the overall goal of getting new drugs to patients faster. Epidiolex has already received orphan drug designation for the treatment of Dravet syndrome in the U.S.

In May 2014, the FDA confirmed that the company’s Investigational New Drug (IND) for Epidiolex for the treatment of Dravet syndrome was open. GW Pharma intends to start a phase II/III study on Epidiolex in the second half of 2014 for the treatment of Dravet syndrome.

GW Pharma also intends to start a phase III study on Epidiolex for the Dravet syndrome indication in the first quarter of 2015.

The company is developing Epidiolex for other indications as well like the treatment of Lennox-Gastaut syndrome (:LGS). GW Pharma intends to initiate two phase III studies on Epidiolex for LGS next year -- a pre-IND meeting with the FDA for this indication is scheduled to be conducted shortly. Epidiolex enjoys orphan drug designation in the U.S. for the LGS indication too.

We are encouraged by GW Pharma’s progress with Epidiolex. The successful development of Epidiolex will be a positive for the company. GW Pharma already has Sativex in its portfolio approved for the treatment of spasticity due to multiple sclerosis in several countries.

GW Pharma, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Gilead Sciences Inc. (GILD), Regeneron Pharmaceuticals, Inc. (REGN) and Alexion Pharmaceuticals, Inc. (ALXN). While Gilead and Regeneron hold a Zacks Rank #1 (Strong Buy), Alexion carries a Zacks Rank #2 (Buy).

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