Ozempic for Weight Loss FDA Approval
The FDA approved onetime-weekly semaglutide injection for chronic weight regulation in adults with obesity or with overweight and at least one weight- related condition, according to an agency press release.
Weekly semaglutide 2.4 mg, a GLP-1 receptor agonist, is the first time Ozempic for weight loss FDA approval of a pharmaceutical for chronic weight regulation in adults with general obesity or overweight since 2014. Ozempic for weight loss FDA approval is indicated for chronic weight regulation in adults with a BMI of 27 kg/ m ² or higher who have at least one weight- related comorbidity, similar as type 2 diabetes or hypertension, or in adults with a BMI of at least 30 kg/ m ².
Semaglutide 1 mg injection (Ozempic for weight loss FDA approval) was first approved for a treatment of type 2 diabetes back in 2017.
“ Ozempic for weight loss FDA approval offers adults that suffer with obesity an advantageous new treatment to incorporate into a weight loss program,” John Sharretts, MD, deputy director of the division of diabetes, lipid diseases and obesity in the FDA’s Center for Medicine Evaluation and Exploration, said in the release. “ FDA remains committed to facilitating the development and approval of added safe and effective therapeutics for adults with obesity or overweight.”
Ozempic for weight loss FDA approval, Safety and efficacy of semaglutide 2.4 mg was assessed in four 68-week trials. Three were randomized, double-blind, placebo- controlled trials, including 16 weeks of dosage increases, and one was a double-blind, placebo- controlled, randomized withdrawal trial in which people assigned Ozempic either continued treatment or switched to a placebo.
Ozempic for weight loss FDA approval, as previously reported, in the STEP 1 study, published in The New England Journal of Medicine in February, adults with obesity assigned semaglutide 2.4 mg endured substantial weight loss compared with placebo, with further than half of participators losing 15% of their body weight. Experimenters found that mean change in body weight from baseline to week 68 was –14.9 for the semaglutide group vs. –2.4 for the placebo group ( estimated treatment difference, –12.4 percentage points; 95 CI, –13.4 to –11.5). Those that were given semaglutide lost a mean –15.3 kg vs. –2.6 kg with placebo ( estimated treatment difference, –12.7 kg; 95 CI, –13.7 to –11.7).
Follow-up data from the STEP 4 study, published in JAMA in March, demonstrated adults with obesity who continued semaglutide 2.4 mg beyond 20 weeks endured continued loss of weight or weight maintenance versus adults who were switched to a placebo.
After randomization, the estimated mean weight change from week 20 to week 68 was –7.9 with continued semaglutide vs. a mean increase of 6.9 among participators switched to placebo ( difference of –14.8 percentage points; 95 CI, – 16 to –13.5). Compared with placebo, waistline circumference dropped from week 20 to 68 ( mean difference, –9.7 cm; 95 CI, –10.9 to –8.5), as did BMI ( mean difference, –4.7; 95 CI, –5.2 to –4.3). Systolic BP remained stable during the maintenance phase for those assigned semaglutide and increased for those assigned placebo ( difference, –3.9 mm Hg; 95 CI, –5.8 to – 2). Physical function scores also bettered in the semaglutide group vs. placebo.
Semaglutide must be increased gradationally over 16 to 20 weeks to2.4 mg once weekly to reduce gastrointestinal side effects, according to Ozempic for weight loss FDA approval.
Semaglutide 2.4 mg shouldn’t be used in combination with other semaglutide- containing products, other GLP-1 receptor agonists or other products intended for weight loss, including prescription medicines, over-the-counter medicines and herbal products, according to the release. Semaglutide2.4 mg has not been studied in people with a history of pancreatitis.
The most common side effects are nausea, diarrhea, puking, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in people with type 2 diabetes, flatulence, gastroenteritis and gastroesophageal influx complaint.
The defining information for semaglutide2.4 mg contains a boxed warning to inform health care professionals and people about the implicit threat for thyroid C- cell growths. Semaglutide shouldn’t be used in people with a particular or family history of medullary thyroid carcinoma or in people with multiple endocrine neoplasia syndrome type 2.
Semaglutide also contains warnings for pancreatitis, gallbladder problems, hypoglycemia, acute order injury, diabetic retinopathy, increased heart rate and suicidal behavior or thinking. However, people should speak with their provider about potentially lowering the dosage of insulin or the insulin- inducing medicine to reduce threat for hypoglycemia, If semaglutide is used with insulin or a substance that causes insulin secretion. FDA stated providers should watch people with kidney complaint, diabetic retinopathy and depression or suicidal actions or thoughts.