15th Sep 2014 13:06
SAINT HELIER (Alliance News) - Shire PLC Monday said the US Food and Drug Administration has accepted for filing with priority review a supplemental New Drug Application for Vyvanse Capsules as a treatment for adults with binge eating disorder.
The FDA is expected to provide a decision in February 2015, the FTSE 100 pharmaceutical company said.
Vyvanse is a prescription medicine currently only approved for Attention-Deficit/Hyperactivity Disorder.
Shire is seeking approval for Vyvanse as a treatment option for adults with binge eating disorder based on the results of two identically designed randomised placebo-controlled Phase 3 studies evaluating the efficacy and safety of Vyvanse versus placebo.
"The decision from the FDA to accept our filing for priority review not only marks progress in the development of Vyvanse for adults with BED, but underscores this is an area of unmet medical need as there are currently no approved pharmacologic options for these patients," said Phil Vickers, the head of research and development at Shire.
Shire shares were flat on Monday, quoted at 5,295 pence.
By Sam Unsted; [email protected]; @SamUAtAlliance
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