Rhythm Pharmaceuticals Announces MHLW Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity (HO) in Japan
Rhythm Pharmaceuticals announced that Japan's MHLW approved IMCIVREE (setmelanotide) for patients with acquired hypothalamic obesity. Approximately 5,000 to 8,000 patients are estimated to be living with acquired HO in Japan, and a commercial launch is expected by the end of 2026 pending final pricing determination.
Why it matters — A regulatory approval in Japan expands the potential market for IMCIVREE beyond its existing indications and adds a new country where Rhythm could commercialise the product.