Drugs

Novo Nordisk Drug Approved for Weight Loss

FDA has approved a Novo Nordisk NDA for Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in overweight adults with at least one weight-related condition (such as high blood pressure, Type 2 diabetes, or high cholesterol). The approval recommends the drug’s use in addition to a reduced calorie diet and increased physical activity. Novo Nordisk’s semaglutide was first approved as a 1 mg injection (Ozempic) in 2017 for treating Type 2 diabetes.

Wegovy works by mimicking the hormone glucagon-like peptide-1 that targets areas of the brain that regulate appetite and food intake, an FDA release says. “The medication dose must be increased gradually over 16 to 20 weeks to 2.4 mg once weekly to reduce gastrointestinal side effects,” it says.

Approval was based on data from four 68-week trials involving 4,100 patients. “The largest placebo-controlled trial enrolled adults without diabetes,” FDA says. “Individuals who received Wegovy lost an average of 12.4% of their initial body weight compared to individuals who received placebo. Another trial enrolled adults with type 2 diabetes. The average age was 55 years and 51% were female. The average body weight was 220 pounds (100 kg) and average BMI was 36 kg/m². In this trial, individuals who received Wegovy lost 6.2% of their initial body weight compared to those who received placebo.”

On the safety side, the most common side effects included nausea, diarrhea, vomiting, constipation, stomach pain, headache, fatigue, dyspepsia (indigestion), dizziness, abdominal distension, eructation (belching), hypoglycemia (low blood sugar) in patients with Type 2 diabetes, flatulence, gastroenteritis (an intestinal infection) and gastroesophageal reflux disease.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome