GlaxoSmithKline and Amicus move Fabry drug Amigal into second Ph III study
UK pharma giant GlaxoSmithKline (LSE: GSK) and partner Amicus Therapeutics (Nasdaq: FOLD) of the USA have revealed that the first patient has commenced dosing in a Phase III global registration study (Study 012) to compare the safety and efficacy of Amigal (migalastat HCl) and enzyme replacement therapy (ERT) for the treatment of Fabry disease.
The randomized, open-label, 18-month study will provide longer-term clinical data comparing migalastat HCl to ERT in patients with Fabry disease, a rare inherited lysosomal storage disorder.
Part of a $230 million deal
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