The U.S. Food and Drug Administration (FDA) has approved a new weekly maintenance dose of a medication for adults living with obesity, giving doctors another option to help adults who need greater weight loss after being on the 2.4 mg dose. Weeks ago, the European Union had also approved this dose for people who need to increase the dose to achieve greater weight loss, and the U.S. regulatory authority granted accelerated approval to Wegovy, semaglutide 7.2 mg—under its priority review program—considering the medication's potential to address critical patient needs and national health priorities in the United States. "Over time, we have come to understand that there is a specific group of patients who require a more potent pharmacological treatment to achieve a greater weight loss," said Dr. Paola Harwicz (M.N. 84.182), a specialist in Cardiology and Nutrition with a focus on Obesity. The expert added: "Today, the patient's health perspective must be holistic, and in that sense, semaglutide has demonstrated in clinical trials to provide cardiometabolic benefits beyond weight loss, such as reducing the risk of heart attack, stroke, and cardiovascular mortality, as well as improving blood glucose control, reducing the accumulation of fatty tissue in the liver, and even reducing mechanical complications associated with excess weight, such as knee osteoarthritis." The approval of this higher dose comes after the analysis of the results of two clinical trials, STEP UP (1,407 participants) and STEP UP T2D (512 participants), involving adults with obesity, with and without type 2 diabetes, respectively. Those who received the 7.2 mg dose once a week, along with lifestyle changes, lost significantly more weight than those who received a placebo. On average, participants with obesity without diabetes who received semaglutide 7.2 mg achieved the following results: Approximately 1 in 3 people lost 25% or more of their body weight. A 21% average body weight loss for those who received Wegovy® 7.2 mg when everyone took the medication as planned, compared to around a 2% weight loss in those who received a placebo. This medication improved body composition. The majority of the weight loss came from fat mass loss (84%), preserving muscle mass. The most common adverse effects were nausea, diarrhea, vomiting (24.8%), and paresthesia (22.9%); they were transient and generally mild to moderate. The medication is injectable and is currently available in doses of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg. These different presentations allow for gradual titration designed to achieve the efficacy and safety profile observed in clinical trials, always under the supervision of a healthcare professional. "This new dose of semaglutide, a molecule whose efficacy and safety we have known for years, has demonstrated a very significant benefit in terms of weight loss with a very good safety profile, a fundamental aspect when increasing the dose," stated Dr. Paola Harwicz.
