November 5, 2013
Plans to Submit a Supplemental New Drug Application (sNDA) by Q3 2014
Shire plc (LSE: SHP, NASDAQ: SHPG) announces positive top-line results from two identically designed randomized placebo-controlled Phase 3 studies evaluating the efficacy and safety of Vyvanse
(lisdexamfetamine dimesylate) Capsules (CII) versus placebo in adults with binge eating disorder (BED). In both studies Vyvanse was found to be statistically superior to placebo on the primary efficacy analysis (p-value <0.001) of the change from baseline at weeks 11 to 12 in terms of number of binge days per week. The safety for Vyvanse in these two studies appears to be generally consistent with the known profile established in studies in adults with Attention-Deficit/Hyperactivity Disorder (ADHD). The Company is reporting the data sooner than originally anticipated because of faster than expected completion of both studies.
"We are extremely pleased with these results, and will be working expeditiously to submit an application to the U.S. Food and Drug Administration for a new indication of BED for Vyvanse, already well established for its efficacy and safety in ADHD," said Flemming Ornskov, M.D., Chief Executive Officer, Shire. "BED is a condition for which there is no currently approved pharmacologic treatment and yet there is significant unmet patient need, as was demonstrated with the faster than expected enrollment of participants in our clinical trial program. Our development of Vyvanse for BED also aligns well with Shire's growth strategy of developing innovative treatments to address significant unmet patient needs."
In addition to the positive top-line primary results, both studies showed statistically significant (p-value <0.001) and consistent treatment effects for Vyvanse across the key secondary efficacy endpoints that have been analyzed thus far in the top-line data. These include the Clinical Global Impressions - Global Improvement (CGI-I), 4-week binge cessation, percent change from baseline in body weight, and change from baseline in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE). Additional analyses continue for other secondary endpoints. Shire anticipates presenting the efficacy and safety data from both studies at a major scientific meeting in 2014. The company plans to file for FDA regulatory approval of Vyvanse for the treatment of BED in adults (ages 18 to 55) by Q3 2014.