California based biopharmaceutical company, KaloBios Pharmaceuticals, Inc. yesterday 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.
Benznidazole is an oral anti-parasitic medication used in the treatment of Chagas disease, caused by a protozoan parasite Trypanosoma cruzi carried and transmitted by triatomine insects (aka “kissing bugs”). According to the Centers for Disease Control and Prevention (CDC), an estimated 300,000 people in the United States are infected with Chagas disease, which, if left untreated, can lead to serious and potentially life-threatening cardiovascular, gastro-intestinal and neurological complications. Benznidazole is the current preferred treatment for Chagas disease in other parts of the world but is not currently approved by the FDA in the U.S.
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.”