28th Feb 2014 13:17
LONDON (Alliance News) - GW Pharmaceuticals PLC Friday said the US Food and Drug Administration has granted its Epidiolex epilepsy treatment orphan drug designation as a treatment for Lennox-Gastaut syndrome, another rare form of childhood epilepsy.
The FDA had already given the cannabidiol drug orphan drug designation for treatment of Dravet syndrome, a genetic epilepsy condition that is drug resistant.
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.
In a statement, GW Pharma said it now intends to advance a full clinical development program for Epidiolex for the treatment of both Lennox-Gastaut syndrome and Dravet syndrome. It said it expects to start an initial phase II clinical trial in the second half of this year.
Lennox-Gastaut syndrome is a severe form of childhood-onset epilepsy. Most children with it experience some degree of impaired intellectual functioning or information processing, along with developmental delays, and behavioral disturbances. The syndrome can be caused by brain malformations, perinatal asphyxia, severe head injury, central nervous system infection and inherited degenerative or metabolic conditions.
GW Pharma said it is estimated that there are approximately 14,000 to 18,500 patients with the syndrome in the US and 23,000 to 31,000 patients in Europe.
"We are now in active discussions with the FDA regarding the US regulatory pathway for Epidiolex and believe that this medicine has the potential to meet the significant unmet need of children suffering with severe seizures where all options to control those seizures have been exhausted," GW Pharma Chief Executive Justin Gover said in a statement.
GW Pharma shares were up 6.4% at 326.25 pence Friday afternoon.
By Steve McGrath; [email protected]; @SteveMcGrath1
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