Rhythm Pharmaceuticals announces marketing authorisation of Imcivree in Great Britain.
“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.