- Britain's Medicines & Healthcare Products Regulatory Agency (MHRA) has approved Rhythm Pharmaceuticals Inc RYTM Imcivree (setmelanotide) for obesity and the control of hunger.
- Related: Rhythm Pharma's Imcivree Gets European Approval For Obesity, Control of Hunger Associated With Genetic Mutations.
- The approval covers adults and children six years of age & above, with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency, or biallelic leptin receptor (LEPR) deficiency.
- Imcivree was selected for evaluation as a "Highly Specialized Technology" by the National Institute for Health and Care Excellence (NICE).
- NICE is scheduled to review the dossier for Imcivree in December 2021.
- Guidance for coverage of Imcivree under the U.K.'s National Health Service (NHS) is anticipated in Q2 of 2022.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: RYTM stock is down 1.19% at $12.42 during the market session on the last check Wednesday.
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