FDA Grants RedHill Fast-Track Designation for Rare Disease Drug

January 8, 2021

RedHill Biopharma has earned the FDA’s Fast-Track designation for RHB-204, an investigational drug being evaluated as a standalone oral treatment for pulmonary nontuberculous mycobacteria (NTM) disease.

The company has also recently received Orphan Drug designation for RHB-204, so the drug could potentially receive up to 12 years of market exclusivity if approved in the U.S. RedHill recently began a phase 3 study that will be conducted at up to 40 U.S. sites.

Pulmonary NTM disease, a serious bacterial infection that can damage the lungs, currently has no first-line treatment approved by the FDA.

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