Amicus Drops Epidermolysis Bullosa Candidate Following Phase III Failure
CEO Crowley points to the need to focus on a pair of Fabry candidates, including the pending NDA for migalastat, and notes that other companies have reached Phase III in EB.
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Amicus plans to file migalastat for Fabry disease in the US in the fourth quarter, after FDA gave the greenlight, reversing a decision last year to require an additional Phase III study.
US FDA recommends company start a new study of oral Fabry disease drug, to be designed using the agency's irritable bowel syndrome guidance for measuring efficacy in diarrhea.
Amicus Therapeutics chairman and CEO John Crowley had special insight into the value of Scioderm's topical drug candidate Zorblisa (SD-101) – he's been a member of the small, private company's board of directors for two years and became convinced that Amicus could add value to the "breakthrough" treatment for epidermolysis bullosa (EB).