Rhythm Pharmaceuticals Secures Expanded FDA Approval for IMCIVREE to Treat Genetic Obesity in Children as Young as 2 Years Old

Expanded Approval:
Rhythm Pharmaceuticals has received FDA approval to expand the indication for IMCIVREE (setmelanotide) to include children as young as 2 years old with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed POMC, PCSK1, and LEPR deficiencies42.

Treatment Indication:
IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long-term in patients 2 years of age and older with these rare genetic obesity conditions4.

Rare Conditions:
The drug targets hyperphagia and obesity in patients with rare melanocortin-4 receptor (MC4R) pathway diseases, including BBS and POMC, PCSK1, and LEPR deficiencies14.

Global Authorization:
IMCIVREE has also received expanded marketing authorization in the UK and EU for patients as young as 2 years old with these conditions35.

Clinical Significance:
Early intervention with IMCIVREE can address the root cause of obesity in young patients, potentially reducing the risk of severe and long-term health complications associated with untreated childhood obesity2.

Sources:

1. https://ir.rhythmtx.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-fda-approval-imcivreer

2. https://www.pharmacytimes.com/view/fda-approves-expanded-indication-for-setmelanotide-to-include-patients-2-and-older

3. https://www.stocktitan.net/news/RYTM/rhythm-pharmaceuticals-announces-imcivree-setmelanotide-receives-s514qi7qr879.html

4. https://www.stocktitan.net/news/RYTM/rhythm-pharmaceuticals-announces-fda-approval-of-imcivree-78uf3eej83ym.html

5. https://ir.rhythmtx.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-v-imcivreer-setmelanotide