David P. Meeker

Notable Quotes

"IMCIVREE is now the first and only FDA-approved therapy for acquired HO, offering a targeted approach that addresses the underlying biology of this disease and meets a critical unmet need for patients who previously had no treatment options." — Statement on FDA approval, March 2026

from FDA expands treatment options for obesity with rare and mainstream drug approvals · Updated May 30

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FDA expands treatment options for obesity with rare and mainstream drug approvals

New Capabilities

Leading Rhythm through its broadest indication expansion

For the first time, patients with acquired hypothalamic obesity have an FDA-approved treatment. On March 19, 2026, the FDA approved Imcivree (setmelanotide), which targets this rare condition affecting roughly 10,000 Americans whose hypothalamic damage from brain tumor surgery makes diet and exercise ineffective.

Updated May 30

David P. Meeker

Notable Quotes

Stories

FDA expands treatment options for obesity with rare and mainstream drug approvals

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