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Merck KGaA’s lupus drug fails to meet primary endpoints in SLE cohort of Phase II trial
Merck KGaA is continuing the development of its lupus therapy enpatoran, despite the drug's failure to meet the primary endpoint in a subgroup of patients with systemic lupus erythematosus (SLE). In the WILLOW study, enpatoran did not achieve the BICLA response after 24 weeks in SLE patients. However, the drug successfully met its primary endpoint in patients with cutaneous lupus erythematosus (CLE), which was reported in October 2024.
Despite the setback, Merck plans to further develop enpatoran. The prevalence of SLE in key global markets is expected to grow modestly, and if approved, enpatoran could generate sales of $85 million by 2030.
Additionally, Merck KGaA received negative topline data from a Phase II study of ompenaclid in metastatic colorectal cancer. Consequently, the company will not pursue U.S. rights for the drug.
14-03-2025