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April 29, 2014
06:07 EDTFOLDAmicus Therapeutics announces positive results from Pahse 3 Fabry study
Amicus Therapeutics announced positive 12- and 24-month data from its first Phase 3 study of the oral small molecule chaperone migalastat HCl monotherapy in Fabry patients with amenable mutations. Study 011 was designed to measure the reduction of disease substrate following treatment with migalastat. The 24-month study began with a 6-month double-blind, placebo-controlled treatment period, after which all patients were treated with migalastat for a 6-month open-label follow-up period and a subsequent 12-month open-label extension phase. As previously reported, patients on migalastat experienced greater reductions in GL-3 as compared to placebo during the initial 6-month period; however, this difference was not statistically significant under the original study primary endpoin
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December 11, 2014
07:32 EDTFOLDAmicus Therapeutics to submit EU MAA for migalastat HCl
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