(Reuters) -Amicus Therapeutics said on Thursday the U.S. Food and Drug Administration (FDA) had approved its therapy to treat a muscle disorder called Pompe disease.
The approval comes after a long delay in bringing the therapy to market. The health regulator last October extended its review for a second time following delays in inspections caused by pandemic-related travel restrictions.
The company was seeking the health regulator’s nod for the expanded use of its therapy, AT-GAA, which is combination of drug migulstat and lab-made protein cipaglucosidase alfa.
The therapy is indicated for use in adults living with late-onset Pompe disease and those without an improvement on their current enzyme replacement therapy, the company said.
Pompe disease is a rare genetic condition in which the body is unable to break down the complex sugar glycogen, leading to a buildup of the same, which causes muscular impairment. The condition may also lead to heart failure in young patients.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shinjini Ganguli)
