Drugs

FDA Approves Diabetes Drug for Weight Loss

FDA has approved a Novo Nordisk NDA for Wegovy (semaglutide) injection (2.4 mg once weekly) for treating adults with obesity or who are overweight with at least one weight-related condition (e.g., high blood pressure, Type 2 diabetes, or high cholesterol). FDA says the subcutaneous injection is the first approved drug for chronic weight management since 2014.

The drug is indicated for chronic weight management in patients with a body mass index of 27 kg/m2. It is intended for use in addition to a reduced calorie diet and increased physical activity. Semaglutide 1 mg injection (Ozempic) was originally approved as a treatment for Type 2 diabetes in 2017.

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

Approval was based on data from two clinical trials. In one trial involving patients without diabetes, FDA says the average body weight of participants was 231 pounds and 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 with an average body weight of 220 pounds, and these individuals lost 6.2% of their initial body weight compared to those who received placebo.

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