The FDA granted fast track designation to
) 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
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
GW Pharma, a biopharmaceutical company, carries a Zacks Rank #3
(Hold). Some better-ranked stocks in the same sector include
Gilead Sciences Inc.
Regeneron Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
). While Gilead and Regeneron hold a Zacks Rank #1 (Strong Buy),
Alexion carries a Zacks Rank #2 (Buy).
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