June 8, 2022
(press release)
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US-based Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and France-based Sanofi announced on Tuesday that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent(R) Medical (dupilumab) to treat adults with prurigo nodularis a chronic skin disease that causes extreme itch and inflammatory skin lesions (nodules). The target action date for the FDA decision is 30 September 2022. Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the US, if approved. The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with prurigo nodularis (PRIME2 and PRIME). According to the companies, both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions. The safety results from these trials were generally consistent with the known safety profile of Dupixent in its approved dermatology indications. The adverse event more commonly observed with Dupixent was conjunctivitis. The FDA grants Priority Review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Additional regulatory filings around the world are also planned in 2022. The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. (C) 2022 M2 COMMUNICATIONS
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