Rhythm Pharmaceuticals announced that the FDA has extended by three months the review period for the supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) for the treatment of acquired hypothalamic obesity. On Nov. 6, the FDA notified the Company that the Prescription Drug User Fee Act (PDUFA) goal date has been extended from December 20, 2025 to March 20, 2026.
The FDA in October requested additional sensitivity analyses of clinical efficacy data from Rhythm’s Phase 3 pivotal trial in acquired hypothalamic obesity. No new data were requested. The additional information has been deemed a ‘major amendment,’ which allows for additional time for the FDA to review. The major amendment did not include any information relating to the safety or manufacturing of setmelanotide.
“Setmelanotide has demonstrated a compelling product profile, and we have every confidence that these additional sensitivity analyses confirm the strength of the data and setmelanotide’s potential to benefit patients with hypothalamic obesity,” said David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm. “We appreciate and continue to collaborate with the FDA review team and we also are continuing to advance our preparations to deliver setmelanotide to a patient community that currently has no treatment options approved for acquired hypothalamic obesity.”
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