The European Commission (EC) has authorised a variation of Rhythm Pharmaceuticals’ Imcivree (setmelanotide) to treat patients with mild, moderate or severe renal impairment.
Imcivree is a melanocortin-4 receptor (MC4R) agonist which is indicated for chronic weight management in adult and paediatric patients aged six years and above with monogenic or syndromic obesity, in the US.
Last year, EC granted marketing authorisation for the therapy to treat obesity and the control of hunger related to 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 this age group.
Now, the regulatory approval allows dosing in POMC or LEPR deficiency patients of the same age group with mild, moderate or severe renal impairment with Imcivree.
The company noted that no dose adjustments are made for mild or moderate renal impairment patients.
For severe renal impairment patients, a separate dose titration schedule is provided.
Furthermore, the treatment is not recommended for last stage renal disease patients.
Rhythm chairman, president and CEO David Meeker said: “We are pleased the EC has recognised the impact Imcivree can have on the lives of patients living with hyperphagia and severe obesity caused by rare MC4R pathway diseases.
“The expansion of the dosing regimen to include patients with renal impairment is an important step in ensuring more patients have access to a therapy that addresses the root cause of these rare genetic diseases.”
The Type II variation application for setmelanotide submitted to the European Medicines Agency (EMA) to treat obesity and control of hunger in same age group patients with Bardet-Biedl syndrome is also under review.
The Committee for Medicinal Products for Human Use (CHMP) of EMA is expected to make recommendation on this application in the third quarter of this year.
Furthermore, the renal impairment dosing amendment is also being considered with the BBS application.