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GSK, Amicus start phase-3 trial of Fabry disease drug

First patient dosed in trial of migalastat hydrochloride

CRANBURY, N.J. — GlaxoSmithKline and Amicus Therapeutics have started a late-stage clinical trial for a drug to treat a rare genetic disorder, the companies said.

GSK and Amicus announced the start of a second phase-3 trial of Amigal (migalastat hydrochloride) for Fabry disease, a rare lysosomal storage disorder that affects between 5,000 and 10,000 people worldwide. The market for Fabry disease has long been dominated by Genzyme, a subsidiary of French drug maker Sanofi that makes the biologic drug Fabrazyme (agalsidase beta).

"In collaboration with GSK, we are pleased to announce the dosing of the first patient in study 012, the first phase-3 pivotal study to compare Amigal to [enzyme replacement therapy]," Amicus chairman and CEO John Crowley said.

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