Rhythm Pharmaceuticals (RYTM) announced the FDA has accepted the company's supplemental New Drug Application for IMCIVREE, a melanocortin-4 receptor agonist, for the treatment of obesity due to Bardet-Biedl syndrome or pro-opiomelanocortin, including proprotein convertase subtilisin/kexin type 1, or leptin receptor deficiency obesity in children as young as 2 years old. The FDA has granted Priority Review of the sNDA and assigned a PDUFA goal date of December 26, 2024.
In the U.S., IMCIVREE is currently indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to POMC, PCSK1 or LEPR deficiency.
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