TrioxBio announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Raviten (MTR-107) for the reduction in hospitalizations or death in patients with end-stage renal disease undergoing hemodialysis and predisposed to developing intradialytic hypotension.
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"Intradialytic hypotension is a serious and frequent complication of hemodialysis; associated with increased morbidity and mortality in hemodialysis patients. It is a high unmet medical need and has no FDA-approved therapies available. The Fast Track designation will enable us to work closely with the FDA to accelerate our efforts to potentially provide an impactful solution for these vulnerable patients," said Shlomo Sadoun, CEO of TrioxBio.
The company plans to initiate Phase II clinical trials for Raviten in the United States later this year.