Merck’s supplemental New Drug Application for Welireg accepted by FDA

Merck announced the FDA has accepted and granted priority review for a supplemental new drug application – sNDA – seeking approval for Welireg, Merck’s oral hypoxia-inducible factor-2 alpha inhibitor, for the treatment of adult patients with advanced renal cell carcinoma following immune checkpoint and anti-angiogenic therapies. The sNDA is based on data from the LITESPARK-005 trial, in which Welireg demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to everolimus based on a pre-specified interim analysis. A statistically significant improvement in the trial’s key secondary endpoint of objective response rate was also demonstrated. The FDA has set a Prescription Drug User Fee Act, or target action, date of January 17, 2024. LITESPARK-005 is part of a comprehensive development program for Welireg, comprised of four Phase 3 trials in RCC, evaluating Welireg in the second-line and treatment-naive advanced disease settings, and LITESPARK-022, evaluating Welireg in the adjuvant setting.