Imcivree Approved to Treat Rare Genetic Conditions That Cause Severe Obesity

November 27, 2020 – The U.S. FDA has approved ImcivreeTM (setmelanotide), manufactured by Rhythm Pharmaceuticals, to provide for chronic weight management for patients who are at least six years old and diagnosed with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. The patient’s condition must be confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). Imcivree is the first drug to receive FDA approval for this indication.

POMC, PCSK1, and LEPR deficiency are extremely rare genetic conditions that impair the body’s ability to regulate hunger and energy expenditure. While patients are typically born at a normal weight, they can experience extreme hunger and an inability to feel full or satiated, leading to early-onset, severe obesity. Imcivree is designed to stimulate activity in an area of the brain that helps control hunger and the feeling of being full. This in turn can help patients better moderate their food intake. Imcivree also helps to increase the body’s resting metabolism, allowing the body to burn more calories, which may contribute to weight loss.

In clinical studies, 80% percent of patients with POMC or PCSK1 deficiency and 46% of patients with LEPR deficiency lost at least 10% of their body weight after being treated with Imcivree for one year. Patients on the medication also experienced decreases in their weekly average maximal hunger scores, though the degree of change was highly variable, and not all patients experienced a change in their scores.

Recommended dosing is based on individual patient factors that include age, treatment tolerability, and weight loss goals. Imcivree is administered daily as a subcutaneous injection, and can be self-administered or administered by a caregiver once the individual has received instruction from a healthcare provider on proper injection technique.

The product has launched at a wholesale acquisition cost (WAC) of $3,300 per vial.