(RTTNews) - Rhythm Pharmaceuticals Inc. (RYTM), a commercial-stage biopharmaceutical company, announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved IMCIVREE (setmelanotide) for the treatment of acquired hypothalamic obesity (HO).

Acquired HO is a rare condition caused by hypothalamic injury that can lead to sustained weight gain, excessive hunger and impaired energy regulation.

IMCIVREE is a melanocortin-4 receptor (MC4R) agonist designed to address the underlying MC4R pathway dysfunction associated with acquired HO.

The Japanese approval was supported by the Phase 3 TRANSCEND trial, which enrolled 142 patients, including 12 from Japan.

The study demonstrated a statistically significant 18.8% placebo-adjusted reduction in BMI.

IMCIVREE is the first approved treatment for acquired HO in Japan, where Rhythm estimates 5,000 to 8,000 people live with the condition.

Separately, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) expanded IMCIVREE's authorization to treat obesity and control hunger in adults and children aged 4 years and older with acquired HO caused by hypothalamic injury or impairment.

The UK authorization was supported by the TRANSCEND study, which showed a 19.8% placebo-adjusted BMI reduction at 52 weeks, along with reductions in hunger.

Rhythm expects to launch IMCIVREE in Japan by the end of 2026, pending final pricing, and plans to work with the UK's National Health Service to finalize coverage guidance.

RYTM has traded $ 74.50 and $ 122.20 over the last year. The stock closed Friday's trade at $110, up 0.99%.

In the pre-market, RYTM is down 0.72% at $109.21.