TEL AVIV, Israel and RALEIGH, NC, Jan. 6, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or "the Company"), a specialty biopharmaceutical company, today announced that RHB-204 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) – a rare disease for which there is no FDA-approved first-line therapy.
RedHill Biopharma Logo RedHill Biopharma Logo The FDA's Fast Track designation is designed to help progress development and speed up the review of novel therapies for serious conditions for which there is an unmet medical need - with the aim of getting important new therapies to patients more quickly. With the Fast Track designation, RedHill will 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.
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