Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with ...
FDA approval follows Phase 3 TRANSCEND trial showing an 18.4% placebo-adjusted BMI reduction in patients with acquired hypothalamic obesity, a condition lacking prior approved treatments.
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FDA expands approval for setmelanotide to patients with hypothalamic obesity
The FDA has approved an expanded indication for setmelanotide to treat children and adults with acquired hypothalamic obesity, Rhythm Pharmaceuticals announced. Setmelanotide (Imcivree, Rhythm Pharmaceuticals) is a melanocortin-4 receptor agonist that was previously approved by the FDA to treat children and adults with obesity due to Bardet-Biedl syndrome, genetically confirmed
Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with ...
- First and only FDA-approved therapy for the treatment of acquired hypothalamic obesity, a rare disease characterized by accelerated and sustained weight gain caused by hypothalamic injury or dysfunction –
Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity
- First and only FDA-approved therapy for the treatment of acquired hypothalamic obesity, a rare disease characterized by accelerated and sustained weight...
Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity - Rhythm Pharmaceuticals (NASDAQ:RYTM)
- First and only FDA-approved therapy for the treatment of acquired hypothalamic obesity, a rare disease characterized by accelerated and sustained weight gain caused by hypothalamic injury or dysfunction – -- Indicated to reduce excess body weight and maintain reduction long term in adults and pediatric patients aged 4 years and older with acquired hypothalamic obesity -- -- Approval based on -18.4% placebo-adjusted BMI reduction achieved by s…
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