Drugs

Lilly Reports Favorable Data in Mounjaro CV Trial

Eli Lilly is reporting favorable data from the SURPASS-CVOT trial that showed its diabetes drug Mounjaro (tirzepatide) matched the cardiovascular benefits of its older drug Trulicity (dulaglutide). The head-to-head 13,000-patient clinical trial found that Mounjaro was non-inferior to Trulicity in preventing major cardiovascular events — defined as cardiovascular death, heart attack, or stroke (MACE-3). It also also demonstrated Mounjaro’s additional health gains in blood sugar control, weight loss, kidney function, and mortality. Trulicity, a GLP-1 receptor agonist, had previously demonstrated cardiovascular benefit in the 2019 REWIND trial.

Lilly also reported that while not formally powered to test for superiority, Mounjaro showed statistically significant improvements across several secondary endpoints. Patients taking Mounjaro experienced greater reductions in A1C levels, body weight, blood pressure, and lipid levels compared to those on Trulicity. Notably, all-cause mortality was 16% lower in the Mounjaro group. The most common side effects for both drugs were mild-to-moderate gastrointestinal issues, consistent with previous studies.

The company says detailed results from SURPASS-CVOT will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting in September and published in a peer-reviewed journal. It also plans to submit the findings to global regulators by the end of the year.

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