UK MHRA approves expanded marketing authorisation of Imcivree in Bardet-Biedl syndrome
Rhythm Pharmaceuticals announced that Great Britain’s Medicines & Healthcare products Regulatory Agency (MHRA) has expanded the marketing authorization for Imcivree (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients 6 years of age and older
Imcivree was selected for evaluation as a “Highly Specialised Technology” by the National Institute for Health and Care Excellence (NICE). The Company plans to work closely with the United Kingdom’s National Health Service (NHS) to finalize guidance for coverage of Imcivree. This follows the announcement of new data from the Company’s long-term extension (LTE) trial, which show continued body mass index (BMI) and weight reductions in patients with Bardet-Biedl syndrome (BBS) or POMC or LEPR deficiency obesity (biallelic) receiving between 18 months and three years of setmelanotide therapy. Rhythm and its collaborators delivered these data in poster presentations at the Endocrine Society Annual Meeting & Expo (ENDO), being held June 11-14, 2022 in Atlanta.
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