Drugs

Lilly Planning Tirzepatide Submission Soon

Eli Lilly says that following positive results from the Phase 3 SURMOUNT-2 trial, it plans to complete in coming weeks an FDA submission for its tirzepatide in adults with obesity or overweight with weight-related comorbidities. A company statement says tirzepatide achieved up to 15.7% weight loss in adults with obesity or overweight and Type 2 diabetes in SURMOUNT-2 compared to placebo. The notice says the study met all co-primary objectives and all key secondary objectives.

Tirzepatide is described as a once-weekly glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide 1 receptor agonist. It is in Phase 3 development for adults with obesity, or overweight with weight-related comorbidity. It also is being studied as a potential treatment for people with obesity and/or overweight with heart failure with preserved ejection fraction, obstructive sleep apnea, and non-alcoholic steatohepatitis. Studies of the drug in chronic kidney disease and in morbidity/mortality in obesity are also ongoing, Lilly says.

FDA approved tirzepatide as Mounjaro on 5/13/22, indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes.

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