FDA Approves Rhythm Pharma sNDA for Imcivree

FDA has approved a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) injection, indicated for chronic weight management in adult and pediatric patients six years of age and older with obesity due to Bardet-Biedl Syndrome (BBS). The therapy was originally approved 11/2020 for chronic weight management in adult and pediatric patients six years of age and older with obesity due to the genetic conditions proopiomelanocortin, proprotein convertase subtilisin/kexin type 1, or leptin receptor deficiency, which cause severe obesity that begins at an early age.

Approval of the sNDA is based on data evaluated in a 66-week trial that enrolled 44 patients with a clinical diagnosis of BBS and obesity, according to an agency release. “After 52 weeks of treatment, patients taking Imcivree lost, on average, 7.9% of their BMI [body mass index],” it says. “Sixty-one percent (61%) of patients lost 5% or more of their BMI, and 39% lost 10% or more of their BMI.”