Rhythm Pharmaceuticals is now selling IM CIVREE in Japan. The drug contains setmelanotide, which helps patients who have acquired obesity. The launch is possible because the medicine was added to Japan’s National Health Insurance price list. IM CIVREE is now the approved treatment for this type of obesity. Acquired hypothalamic obesity can happen when the hypothalamus, a part of the brain that controls hunger, energy and weight is damaged.<\/p>
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When the hypothalamus is damaged hunger signals and the body’s energy use can become upset. The result is hunger and quick weight gain. These changes make it very hard for patients to keep their weight under control.<\/p>
IM CIVREE works by activating the melanocortin‑4 receptor or MC4R pathway. This pathway helps regulate hunger and energy balance. Setmelanotide, which is, in IM CIVREE targets this pathway to fix the problems that cause acquired hypothalamic obesity.<\/p>
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Japan’s regulatory approval was supported by results from the Phase 3 TRANSCEND trial. The global study included 142 patients with acquired obesity. This group had 12 patients from Japan and 10 additional participants outside the 120-patient pivotal cohort.<\/p>
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The results offer proof that the treatment can help people with acquired hypothalamic obesity. Clinical studies are still key, to understanding both the benefits and risks. As the medicine becomes available in Japan doctors and healthcare professionals will have to assess how best to use it. They will need to monitor patients and take into account each person’s medical history and condition following the approved product information.<\/p>
The commercial launch followed IMCIVREE’s addition to Japan’s National Health Insurance drug price list. This step establishes the medicine’s listed price within the country’s public health insurance system and supports its introduction into routine healthcare channels.<\/p>
The development also shows how Japan’s regulatory and reimbursement processes play a role in getting treatments for rare diseases into the hands of patients. Marketing authorization means a medicine can be sold for its approved use.. Pricing and reimbursement are just as important because they determine whether patients can actually get the medicine in practice.<\/p>
Rhythm said it has been growing its team in Japan to get ready for the launch. The company’s international operations will help support its work to make the medicine available to patients and to healthcare providers across the country.<\/p>
How many patients end up getting the treatment will depend on how many’re diagnosed, whether they meet clinical criteria how much healthcare professionals know about the condition and how well the medicine fits into Japan’s healthcare system. The company estimates that between 5,000 and 8,000 people, in Japan have the condition. That number is the potential patient population, not the number expected to actually receive treatment.<\/p>
The Japanese launch is a part of Rhythm Pharmaceuticals’ efforts focused on rare neuroendocrine diseases. The company is working on treatments that focus on the pathways that control hunger and body weight.<\/p>
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Rhythm Pharmaceuticals is now selling IM CIVREE in Japan. The drug contains setmelanotide, which helps patients who have acquired obesity. The launch is possible because the medicine was added to Japan’s National Health Insurance price list. IM CIVREE is now the approved treatment for this type of obesity. Acquired hypothalamic obesity can happen when the hypothalamus, a part of the brain that controls hunger, energy and weight is damaged.The launch comes after the Ministry of Health Labour and Welfare approved the drug in August 2026. Rhythm Pharmaceuticals estimates that about 5,000 to 8,000 people in Japan have acquired obesity. Rhythm Pharmaceuticals had also earned orphan drug status for setmelanotide for […]<\/p>\n","protected":false},"author":7,"featured_media":40210,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"wprm-recipe-roundup-name":"","wprm-recipe-roundup-description":"","postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""},"footnotes":""},"categories":[89,8098,182],"tags":[16308,16309,16310,314,16311],"ppma_author":[572],"class_list":["post-40179","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health-tech","category-news-articles","category-pharma","tag-drug-contains","tag-hypothalamic-obesity","tag-im-civree","tag-japan","tag-rhythm-pharmaceuticals"],"yoast_head":"\n