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KaloBios Pharmaceuticals, Inc. announced positive guidance in the minutes from a recent meeting with the U.S. Food and Drug Administration (FDA) to discuss the development plans for benznidazole for the treatment of Chagas disease, a neglected tropical disease.
Meeting minutes received from the FDA's Division of Anti-Infective Products confirmed key elements of the company's overall plan for benznidazole, including:
• The company's proposed 505(b)(2) approach to demonstrate safety and efficacy using some data drawn from previously conducted studies is acceptable to FDA.
• If approved as a treatment for Chagas, benznidazole is currently expected to be eligible for a priority review voucher (PRV), awarded to sponsors of certain treatments for neglected tropical diseases that meet criteria specified by the Federal Food, Drug, and Cosmetic (FD&C) Act
"This guidance makes it clear that we are on the right track with our development of benznidazole for Chagas disease, and we expect we will progress expeditiously toward a submission," said Cameron Durrant, MD, KaloBios chairman and CEO. "Our team continues to execute and we look forward to further collaborative engagement with FDA."
