Accelerated Approval Pathway In a statement issued by Amicus today, the elder Crowley said the NDA will be submitted under the FDA's Subpart H pathway, created last year to enable accelerated approval of drug candidates indicated for "serious or life-threatening illnesses." "This guidance from the FDA marks a tremendous step forward for thousands of people living with Fabry disease in the United States," CEO Crowley stated. "We are moving ahead expeditiously with our NDA submission and accelerating the U.S. pathway for migalastat. Today is a seminal moment in the development of migalastat and a testament to the dedication and perseverance of the patients, physicians, and employees who have worked so hard on the development of this precision medicine." Amicus said it intends to base its NDA on existing data, including reduction in the disease-causing substrate globotriaosylceramide (GL-3), as well as the totality of data from completed clinical studies.