FDA nod for Imcivree, a first for chronic weight management

27 November 2020

The US Food and Drug has approved Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients six years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing.

With this approval, US biotech Rhythm Pharmaceuticals’ (Nasdaq: RYTM) Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. Rhythm’s shares leapt 25.6% to $30.35 by midday.

The company expects to make Imcivree commercially available in USA in first-quarter 2021. Rhythm’s marketing application for setmelanotide to treat people living with obesity is currently under European Medicines Agency review.

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