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Rhythm Pharmaceuticals announces marketing authorisation of Imcivree in Great Britain.

Read time: 1 mins
Published: 23rd Sep 2021
Rhythm Pharmaceuticals, Inc. announced that Great Britain’s Medicines & Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to Imcivree (setmelanotide) for the treatment of obesity and the control of hunger associated 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 in adults and children 6 years of age and above.

“This is a significant step for individuals living with the severe obesity and insatiable hunger, known as hyperphagia, that characterise POMC, PCSK1 or LEPR deficiency,” said Sadaf Farooqi, M.D., Ph.D., professor at the Wellcome-MRC Institute of Metabolic Science and NIHR Cambridge Biomedical Research Centre. “Until today, there were no authorised therapies that address the impairments in the melanocortin-4 receptor (MC4R) pathway that drive these rare diseases. With Imcivree, eligible patients now may have access to a pharmacological therapy specifically intended to address the underlying cause of their disease.”

Imcivree was selected for evaluation as a “Highly Specialised Technology” by the National Institute for Health and Care Excellence (NICE). NICE is scheduled to review the dossier for Imvcivree by December 2021. Guidance for coverage of Imcivree under the United Kingdom’s National Health Service (NHS) is anticipated in the second quarter of 2022.

Condition: Pro-opiomelanocortin (POMC) Deficiency Obesity
Type: drug
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