The FDA approved today (7/31) RedHill Biopharma’s investigational new drug (IND) application for phase 3 of RHB-204 for pulmonary NTM infection in adults. NTM (nontuberculous mycobacteria) is a chronic lung disease caused by environmental bacteria typically near natural and engineered water systems that can lead to pneumonia, bronchitis, fevers, chest pain, and weight loss. Redhill BioPharma’s Chief Operating Officer, Gilead Raday, said, “There is currently no FDA-approved first-line, standard-of-care therapy for patients suffering from pulmonary NTM infections. We are looking forward to completing our discussions with FDA and initiating this pivotal study at leading clinical sites across the U.S., evaluating RHB-204 as a first-line, stand-alone, orally-administered therapy.”
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