Drugs

FDA OKs Lilly's Mounjaro to Reduce CV Risk in Adults with Diabetes

FDA has approved Eli Lilly’s Mounjaro (tirzepatide) for lowering the risk of major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal heart attack, or non-fatal stroke in adults with Type 2 diabetes who are at high risk for such events. The dual GIP and GLP-1 hormone receptor agonist is currently approved as an adjunct to diet and exercise to improve blood sugar in adults and children 10 years of age and older with Type 2 diabetes.

Approval was based on data from SURPASS-CVOT, “the first cardiovascular outcomes trial comparing two incretin medicines head-to-head rather than against a placebo, and the largest and longest tirzepatide study to date, enrolling more than 13,000 participants across 30 countries over more than four and a half years,” the company says.

In the trial, Mounjaro demonstrated non-inferiority to Lilly’s Trulicity (dulaglutide), a GLP-1 treatment with established cardiovascular benefit, with an 8% lower rate of cardiovascular death, heart attack or stroke (MACE-3), it says.

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