12:00 AM
Feb 18, 2013
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Migalastat: Additional Phase III data

Amicus reported data from a post hoc analysis of the modified intent-to-treat (mITT) population (n=60) from the double-blind, placebo-controlled, international Phase III FACETS (Study 011) trial in 67 patients with Fabry's disease evaluating 150 mg oral Amigal given every other day. In patients with a higher baseline disease burden (n=25), defined as >=0.3 GL-3 inclusions per kidney interstitial capillary, 64% of patients receiving Amigal achieved a >=50% reduction in kidney interstitial capillary GL-3 levels as measured in kidney biopsies from baseline to 6 months, the primary endpoint, vs. 14% for placebo. In patients with a lower baseline disease burden (n=35), 32% of patients receiving Amigal achieved the endpoint vs. 44% for placebo. The company...

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