Rhythm Pharmaceuticals launches IMCIVREE in Japan for obesity

TOKYO - Rhythm Pharmaceuticals Inc. has officially introduced IMCIVREE, a new treatment targeting acquired hypothalamic obesity in Japan. This marks the first approval of a therapy specifically for this condition in the country, following its addition to Japan's National Health Insurance drug price list. IMCIVREE received approval from Japan's Ministry of Health, Labour and Welfare in August, based on data from the Phase 3 TRANSCEND trial.

The trial, which included 142 patients with acquired hypothalamic obesity, showed an 18.8% placebo-adjusted reduction in body mass index. Rhythm Pharmaceuticals estimates that around 5,000 to 8,000 people in Japan are affected by acquired hypothalamic obesity. In the United States, the drug is already approved for the same use, as well as for other specific genetic obesity conditions.

The European Commission and the UK's Medicines and Healthcare Products Regulatory Agency have also authorized IMCIVREE for these indications. Founded as a commercial-stage biopharmaceutical company, Rhythm Pharmaceuticals focuses on rare neuroendocrine diseases, with headquarters in Boston.