Diabetes Drug Cuts Body Weight, Seeks FDA Approval as Obesity Treatment


2021-02-12 07:30:13 BioSpace


joreks/Shutterstock Novo Nordisk is positioning its type 2 diabetes treatment Ozempic (semaglutide) as an anti-obesity treatment. Data published in the New England Journal of Medicine shows the once-weekly dose of the glucagon-like peptide-1 (GLP-1) analog significantly reduced weight in patients over the course of 68 weeks. The data published in the journal showed that semaglutide provided significant weight loss benefit to adults with a body-mass index of 30 or greater who did not have diabetes. Over the course of 68 weeks of treatment, those patients who received a subcutaneous dose of 2.4 mg of semaglutide saw a mean change in body weight of -14.9%. That compared to a mean change of -2.4% in the placebo group. Obesity is a chronic disease that requires long-term management. It is associated with many serious health consequences and decreased life expectancy. Obesity-related complications are numerous and include type 2 diabetes, heart disease, obstructive sleep apnea, non-alcoholic fatty liver disease and cancer. Ozempic was first approved for type 2 diabetes in 2017 as an adjunct to diet and exercise to improve glycemic control. Last year, the drug was approved to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease. An oral form of semaglutide has also been approved for type 2 diabetes sold under the brand name Rybelsus. According to the data in the NEJM, 1082 patients who received semaglutide, about 86%, achieved weight reductions of at least 5%. Of those, 838 saw a 10% reduction and 612 saw a weight loss of more than 15%, the researchers said. Semaglutide induces weight loss by reducing hunger, increasing feelings of fullness and thereby helping people eat less and reduce their calorie intake, Novo Nordisk said. Overall, the change in body weight at the end of 68 weeks was a 15.3 kg loss, about 33.3 pounds. The placebo group saw an average weight reduction of 2.6 kg, a little under 6 pounds. Participants who received semaglutide had a greater improvement with respect to cardiometabolic risk factors and a greater increase in participant-reported physical functioning from baseline than those who received placebo, the researchers said. While semaglutide has been shown to be safe, the research shows more participants in the semaglutide group discontinued treatment owing to gastrointestinal events. Nausea and diarrhea were the most common adverse events described. The research posted in NEJM should lend support to a New Drug Application Novo Nordisk filed with the U.S. Food and Drug Administration in December for semaglutide in this indication. The company anticipates a fast turn-around for this. It applied a priority review voucher to the NDA, which means the FDA will review the application within six months. The potential indication is for the treatment of obese adults (BMI greater than 30) with at least one weight-related comorbidity, as an adjunct to reduced-calorie diet and increased physical activity. The NDA is based on data from Novo Nordisk’s Phase III STEP (Semaglutide Treatment Effect in People with obesity) program. “Obesity is associated with a wide range of serious complications, yet many healthcare providers still do not have sufficient medical options available to help people with this chronic disease,” Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk, said in a statement. “We are excited about the regulatory filing of semaglutide 2.4 mg in the US and we believe once-weekly semaglutide 2.4 mg has the potential to transform the medical management of obesity.” Most Read Today
Joreks/Shutterstock 诺和诺德公司将其2型糖尿病治疗药物Ozempic(semaglutide)定位为抗肥胖治疗。发表在《新英格兰医学杂志》上的数据显示,每周一次的胰高血糖素样肽-1(GLP-1)类似物在68周的疗程中显著降低了患者的体重。 发表在该杂志上的数据显示,对于体重指数为30或更高且没有糖尿病的成年人来说,semaglutide提供了显著的减肥益处。在68周的治疗过程中,那些接受皮下剂量为2.4毫克的施马鲁肽的患者看到体重的平均变化为-14.9%。而安慰剂组的平均变化为-2.4%。 肥胖是一种慢性疾病,需要长期管理。它与许多严重的健康后果和预期寿命缩短有关。肥胖相关的并发症很多,包括2型糖尿病、心脏病、阻塞性睡眠呼吸暂停、非酒精性脂肪肝和癌症。 Ozempic于2017年首次被批准用于2型糖尿病,作为饮食和运动的附属品,以改善血糖控制。去年,该药被批准用于降低患有2型糖尿病和已知心脏病的成年人发生心脏病发作、中风或死亡等主要不良心血管事件(MACE)的风险。一种口服形式的semaglutide也已被批准用于2型糖尿病,其品牌名称为Rybelsus。 根据NEJM的数据,1082名接受了西马鲁肽治疗的患者,约占86%,体重至少减轻了5%。研究人员说,其中838人体重减轻了10%,而612人体重减轻了15%以上。Novo Nordisk公司表示,Semaglutide通过减少饥饿感、增加饱腹感来减轻体重,从而帮助人们少吃并减少卡路里的摄入。 总体来说,68周结束时体重的变化是减少了15.3公斤,大约33.3磅。安慰剂组平均体重减少了2.6公斤,略低于6磅。 研究人员说,与那些接受安慰剂的人相比,接受semaglutide的受试者在心脏代谢危险因素方面有更大的改善,并且受试者报告的身体功能比接受安慰剂的受试者有更大的提高。 虽然西马鲁肽已被证明是安全的,但研究显示西马鲁肽组更多的参与者由于胃肠道事件而停止治疗。恶心和腹泻是所描述的最常见的不良事件。 这项发表在NEJM上的研究应该可以支持诺和诺德公司去年12月向美国食品和药物管理局提交的一项新药申请,该申请涉及该适应症中的semaglutide。该公司预计这将很快扭转局面。它向NDA申请了优先审查凭证,这意味着FDA将在六个月内审查申请。潜在的适应症是用于治疗至少有一种体重相关共病的肥胖成人(BMI大于30),作为降低热量饮食和增加体力活动的辅助。NDA是基于诺和诺德的第三阶段STEP(斯马鲁肽在肥胖人群中的治疗效果)项目的数据。 诺和诺德公司执行副总裁兼首席科学官Mads Krogsgaard Thomsen在一份声明中说:“肥胖与广泛的严重并发症有关,然而许多医疗保健提供者仍然没有足够的医疗选择来帮助患有这种慢性病的人。”“我们对2.4毫克的semaglutide在美国的监管备案感到兴奋,我们相信每周一次的semaglutide 2.4毫克有可能改变肥胖症的医疗管理。” 今天阅读最多的