Imago BioSciences announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of IMG-7289 (bomedemstat) for the treatment of Essential Thrombocythemia. This follows the Fast Track designation for the same drug in Myelofibrosis in August 2019.
“The Fast Track designation by the FDA recognizes the need for novel therapeutics for myeloid diseases and mirrors our own urgency in addressing these devastating conditions,” said Hugh Young Rienhoff, Jr. M.D., CEO, Imago Biosciences. “ET is a quiet bone marrow cancer than can linger for years. In a subset of patients, the excess of platelets leads to bleeding and clotting including strokes and infractions, each having a significant impact on these patients. With only one FDA approved therapy, one that does not increase overall survival, patients are in desperate need of new options. Based on its mechanism and safety data obtained to date, we believe bomedemstat has the promise to be that new treatment.”
According to the FDA, “Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.” Click here to learn more about Fast Track.