Wegovy FDA Approval History
Karine Wardill 于 1 天之前 修改了此页面


The indication for MASH is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial. CV events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight. Concomitant use of Wegovy injection or tablets with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended. Wegovy works in the treatment of obesity or overweight by decreasing caloric intake through activation of GLP-1 receptors, which are present in several areas of the brain involved in appetite regulation. Wegovy is thought to work in the treatment of MASH through multiple pathways mediated by weight loss and other factors. Wegovy injection is administered by subcutaneous injection (into the abdomen, thigh, or upper arm) once weekly, with or without meals. Wegovy tablets are administered orally once daily on an empty stomach. The Wegovy product label carries a boxed warning for an increased risk of thyroid C-cell tumors. Warnings and precautions include acute pancreatitis, acute gallbladder disease, hypoglycemia, acute kidney injury, hypersensitivity reactions, diabetic retinopathy complications in patients with type 2 diabetes, increased heart rate, MedicGLP and MedicGLP Official Support suicidal behavior and ideation, and pulmonary aspiration during general anesthesia or deep sedation. Common adverse reactions (incidence ≥5%) in adults or pediatric patients aged 12 years and older include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.


Science continues to prove that the old adage "you are what you eat" is profoundly true. This is because you have trillions of microorganisms living in your gut, which are directly responsible for nearly every aspect of your health. These microbes make up what’s called your "gut microbiota." They are especially influential in determining your likelihood of gaining excessive weight, becoming obese, and developing obesity-related diseases like diabetes, heart disease, and premature death. The gut microbiome (the expressed genes of your gut microbiota) plays a major role in your metabolism through energy production, storage, and expenditure. So, it’s no surprise that science has found a strong connection between gut microbiome imbalance and metabolic syndrome. Yikes! If you have the wrong mix of microbes, it could be making it tough for you to get your health on track! Did you know: Scientists can actually look at your gut microbiome composition and tell with 90% accuracy if you are obese or lean. That’s pretty impressive, isn’t it?


1. Unable to lose weight and keep it off? 2. Struggling to fight cravings? 3. Sick of starving yourself for weight loss? 4. Baffled as to why no diet seems to really work for you? Depending on the composition of your gut microbiome, your microbes can either boost your health or weigh you down (figuratively and literally). The good news is this: You have control over these little guys with every bite you eat. Diet has the power to change the landscape of your gut microbiome. So, if you’ve tried multiple diets and can’t seem to get the results you want, it’s time to look into your gut microbiome.Will You Lose Weight Naturally on an Individualized Diet? If you’ve been struggling to lose weight and keep it off - it could be your gut microbiome. While Viome doesn’t guarantee weight loss, it has been an exciting result many of our customers have reported. "Fiona’s update day 37!


We know weight loss can be tough. Find out if your weight struggles are due to a gut microbiome imbalance with Viome - and let’s tip the scales in your favor. Your gut microbes actually digest much of your food for you. When your gut microbiota help digest your food, they turn it into nutrients, neurotransmitters, vitamins, hormones, and more. Through these metabolites, the composition of your gut microbiome influences nearly every metabolic activity. It’s accurate to think of your gut microbiome as an organ that’s part immune system and part energy regulator. If your gut microbiome is imbalanced, certain bacteria end up working to protect themselves from the harsh environment and are not able to help you. In the worst case scenario, you can have microbiota adding to your health problems, making it harder for you to get healthy and lose weight. Viome’s metatranscriptomic technology has allowed us identify microbial pathways and functions, specifically those that influence weight loss or gain.