Rhythm Pharma: MHRA Expands Marketing Authorization For IMCIVREE - Quick Facts

(RTTNews) - Rhythm Pharmaceuticals (RYTM) announced that the United Kingdoms Medicines & Healthcare products Regulatory Agency or MHRA has expanded the marketing authorization for IMCIVREE or setmelanotide to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome or genetically confirmed loss-of-function biallelic pro-opiomelanocortin, including proprotein convertase subtilisin/kexin type 1, deficiency or biallelic leptin receptor deficiencyin adult and pediatric patients as young as 2 years old and older.

IMCIVREE initially received marketing authorization from the MHRA as an option for treating obesity and control of hunger in patients aged 6 years and older in these indications in 2022. A supplemental New Drug Application for IMCIVREE for patients as young as 2 years of age is currently under priority review with the FDA, with an assigned PDUFA goal date of December 26, 2024.

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