The European Commission has granted Orphan Drug Designation to RedHill Biopharma’s RDHL lead asset RHB-204 for the treatment of nontuberculous mycobacteria (NTM) disease.
The regulatory grant follows a positive opinion recommendation on RHB-204 by the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP).
RHB-204 is being evaluated in a Phase 3 clinical study in the United States for adults with pulmonary NTM disease caused by Mycobacterium avium complex (MAC) infection.
Patricia Anderson, SVP Regulatory Affairs, commented: "NTM infections are increasing across the world and they are notoriously difficult to treat. There are no approved first-line stand-alone therapies in the U.S, EU, and Japan, highlighting the significant need for new options to treat this challenging and debilitating infectious disease.”
RedHill is facilitating discussions with prospective partners for RHB-204 across multiple territories.
RHB-204 was granted Fast Track, Orphan and QIDP priority designations by the U.S. FDA.
The EMA grants Orphan status to treatments of a life-threatening or chronically debilitating condition that is rare. Orphan Designation provides for free protocol assistance potential reductions in fees, and eligibility for 10 years post-launch market exclusivity.
Price Action : RedHill shares are trading around 6 percent higher at $1.04 on Wednesday at the time of publication.
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