In a $100 million deal, Rhythm Pharmaceuticals is selling its rare pediatric disease priority review voucher (PRV), granted by the U.S. Food and Drug Administration (FDA) with the approval of Imcivree (setmelanotide) to treat three rare genetic obesity disorders. …
One year of treatment with setmelanotide was safe and resulted in a significant drop in body weight and hunger in Bardet-Biedl syndrome (BBS) patients, ages 12 years and older, with moderate to severe obesity, according to top-line data from a Phase 3 clinical trial. “We are pleased with…
The U.S. Food and Drug Administration (FDA) has approved Imcivree (setmelanotide) as the first-ever treatment for people, 6 and older, with POMC deficiency, PCSK1 deficiency, and LEPR deficiency, three rare genetic obesity disorders. The company expects that Imcivree will be available to eligible patients in…
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