Drugs

Lilly Retatrutide Meets Key Primary, Secondary Endpoints

Lilly says its triple agonist retatrutide met all key primary and secondary endpoints in the Phase 3 TRANSCEND T2D-1 trial that evaluated its efficacy and safety in treating adults with type 2 diabetes. A company statement says retatrutide is a first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist being investigated as an adjunct to diet and exercise in diabetes treatment.

The drug lowered A1C by an average of 1.7% to 2.0% across doses at 40 weeks, Lilly says, and trial participants who took a 12 mg dose lost an average of 36.6 (17%) pounds. The statement says retatrutide also showed meaningful clinical improvements from baseline across key risk factors, including non-HDL cholesterol, triglycerides, and systolic blood pressure. The most common adverse effects were nausea, diarrhea, and vomiting, and occurred primarily during dose escalation, the company says.

Lilly says retatrutide is an investigational once-weekly triple hormone receptor agonist. The company is studying it in several Phase 3 trials to evaluate its potential efficacy and safety in obesity and overweight with at least one weight-related medical problem, type 2 diabetes, knee osteoarthritis, moderate-to-severe obstructive sleep apnea, chronic low back pain, cardiovascular and renal outcomes, and metabolic dysfunction-associated steatotic liver 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