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RedHill Biopharma: FDA Grants Fast Track Designation To RHB-204 For NTM Disease

RedHill Biopharma Ltd. (RDHL) said Wednesday that the U.S. Food and Drug Administration or FDA has granted Fast Track designation to RHB-204 for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC). This is a rare disease for which there is no FDA-approved first-line therapy.

The FDA's Fast Track designation is intended to help progress development and speed up the review of novel therapies for serious conditions for which there is an unmet medical need.

RedHill noted that the Fast Track designation will enable the company to have access to early and frequent communications with the FDA, to expedite the RHB-204 development program, and to a rolling review of a New Drug Application (NDA).

Having already been granted Qualified Infectious Disease Product (QIDP) designation, RHB-204 is also eligible for NDA Priority Review and Accelerated Approval.

RHB-204 was also recently granted Orphan Drug designation, extending U.S. market exclusivity for RHB-204 to a potential total of 12 years upon FDA approval.

RedHill recently initiated a Phase 3 study evaluating the safety and efficacy of RHB-204 as a first-line treatment for pulmonary NTM disease, to be conducted at up to 40 sites across the U.S.

Pulmonary nontuberculous mycobacteria or NTM disease is a chronic and debilitating lung disease caused by ubiquitous environmental bacteria found in soil, as well as natural and engineered water systems.

There were an estimated 110,000 pulmonary NTM disease patients in the U.S. in 2017, with U.S. market potential estimated at over $500 million. Pulmonary manifestations account for 80 percent to 90 percent of all NTM-associated diseases, and about 80 percent of pulmonary NTM disease are caused by MAC.

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