Drugs

Characterize Obesity as a Chronic Disease: Lilly

Eli Lilly, which recently obtained FDA approval for its Zepbound (tirzepatide) as a weight-loss drug, says that as the agency revises its 2007 guidance on developing products for weight management it should clearly state that obesity is a complex, chronic disease. In a comment letter, Lilly says such a characterization should be reflected in approved product labeling.

The company also calls on FDA to “incorporate the most recent scientific understanding of obesity into the revised draft guidance.” In particular, it says the agency should consider whether Body Mass Index alone is a reliable and equitable indicator of obesity. Lilly recommends that in addition to overall weight reduction, new clinical endpoints that include measures of adiposity are needed for future clinical trials of weight loss products

The company calls for a prompt revision of the guidance “in a manner that reflects the evolving view of obesity as a disease, provides updated recommendations for industry on appropriate criteria for identifying patients with obesity for inclusion in clinical trials, and addresses the need for new measures of effectiveness that can adequately support the development of new treatments for obesity.”

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