Amicus Therapeutics Inc said on Tuesday the European Commission approved the use of migalastat, its experimental treatment for Fabry disease, an inherited disease that creates pain and burning in the hands and feet.
The European Medicines Agency had recommended approving migalastat in April. The Cranbury, New Jersey-based company is still seeking approval from U.S. regulators.
Fabry disease is a potentially fatal disorder that affects about 1 in 40,000 to 60,000 men and occurs less frequently in women. It is caused by the build-up of fat-like substances, most notably in the kidneys, due to the deficiency or lack of an enzyme that metabolizes these lipids.
The accumulation damages cells and can lead to kidney failure, heart attacks and strokes. It is currently treated with metoclopramide.
The U.S. Food and Drug Administration last fall asked Amicus for more comprehensive analysis of its trial data and the company put off submitting a new marketing application for the treatment.
(Reporting by Noor Zainab Hussain in Bengaluru and Caroline Humer in New York; Editing by Sriraj Kalluvila and Jeffrey Benkoe)