Amicus Completes End-of-Phase II Meeting With FDA

Amicus Therapeutics has completed an end-of-Phase II meeting with the FDA for Amigal, a treatment for Fabry disease.

A lysosomal storage disorder, Fabry disease can damage the kidneys, heart, nervous system and skin.

Results from the Phase II trial showed the drug was safe and well tolerated, and it increased activity of an enzyme deficient in patients with the disease. The FDA indicated that the data supported the start of Phase III development and agreed that the drug met criteria to be considered for accelerated approval, Amicus said.