Rhythm Pharmaceuticals Inc., a global commercial-stage biopharmaceutical company, has announced significant progress in its regulatory review process. The company remains on track to submit a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) and a Type II variation request to the European Medicines Agency for its drug, setmelanotide, targeted at treating patients with acquired hypothalamic obesity. This follows the successful achievement of the primary endpoint in a pivotal Phase 3 trial, which demonstrated a -19.8% placebo-adjusted BMI reduction in 120 patients. Additionally, Rhythm Pharmaceuticals is anticipated to complete enrollment in a Phase 3 trial substudy investigating the use of setmelanotide in congenital hypothalamic obesity by the second half of 2025.
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