The FDA will decide whether or not to approve Amicus Therapeutics Inc.’s (FOLD) Migalastat as a monotherapy for Fabry disease in patients with amenable mutations on August 13, 2018.Fabry disease is a genetic disease which causes deficiency of an enzyme called alpha-galactosidase A (alpha-Gal A), which is the result of mutations in the GLA gene. An estimated 35% to 50% of the Fabry population has amenable mutations.Reduced or absent levels of alpha-Gal A activity lead to the accumulation of GL-3 in the affected tissues, including the central nervous system, heart, kidneys, and skin.Progressive accumulation of GL-3 is believed to lead to the morbidity and mortality of Fabry disease, including pain, kidney failure, heart disease, and stroke.Migalastat is approved under brand name Galafold in European Union, Australia, Canada, Israel, South Korea, Switzerland, and Japan.Galafold is the first and only oral precision medicine for Fabry disease.Galafold’s annual revenue totaled approximately $36 million in 2017.FOLD closed Wednesday’s (Jul 25) trading at $15.38, down 1.91%.