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.
Related news and insights
Medtronic announced the United States launch of the Penditure left atrial appendage (LAA) exclusion system, an implantable clip preloaded on a single-use delivery system for LAA management during concomitant cardiac surgery procedures
GSK plc announced positive headline results from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase III trial evaluating belantamab mafodotin as a second-line treatment for relapsed or refractory multiple myeloma