IMCIVREE (setmelanotide) PDUFA Date (Rhythm Pharmaceuticals)

Name: FDA PDUFA Decision: IMCIVREE (setmelanotide)
Start: 2026-03-20

FDA PDUFA decision date for IMCIVREE (setmelanotide) is March 20, 2026. Developed by Rhythm Pharmaceuticals. Indication: Acquired hypothalamic obesity (expanded use). Current status: Approved.

Indication

Acquired hypothalamic obesity (expanded use)

Regulatory details

Company: Rhythm Pharmaceuticals
Therapeutic area: Rare Disease / Metabolic
Application type: sNDA
Review type: Priority
PDUFA date: 2026-03-20
Outcome: Approved

IMCIVREE (setmelanotide) PDUFA Date — Rhythm Pharmaceuticals