The FDA grants a Fast Track designation for a treatment for primary mitochondrial myopathy.
A drug candidate discovered by Peter W. Schiller, Director of the Chemical Biology and Peptide Research unit at the Institut de recherches cliniques de Montréal (IRCM) and Research Professor in the Department of Pharmacology of the Université de Montréal, has been granted Fast Track designation by the Food and Drug Administration (FDA) for the treatment of primary mitochondrial myopathy. The candidate, elamipretide (formerly known as Bendavia), is being developed by Stealth BioTherapeutics Inc.
About the IRCM
Founded in 1967, the Institut de recherches cliniques de Montréal (IRCM) / Montreal Clinical Research Institute is a non-profit organization that conducts fundamental and clinical biomedical research in addition to training high-level young scientists. With its cutting-edge technology facilities, the Institute brings together 33 research teams working in cancer, immunology, neuroscience, cardiovascular and metabolic diseases, systems biology and medicinal chemistry. The IRCM also operates a research clinic specialized in hypertension, cholesterol, diabetes and cystic fibrosis, as well as a research centre on rare and genetic diseases in adults. The IRCM is affiliated with Université de Montréal and associated with McGill University. Its clinic is affiliated with the Centre hospitalier de l’Université de Montréal (CHUM). The IRCM is supported by the Ministère de l’Économie, de la Science et de l’Innovation (Quebec Department of Economy, Science and Innovation).
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