Drugs

sNDA for Ozempic Planned for Kidney Disease

Novo Nordisk says it will file a supplemental NDA this year seeking an expanded label for Ozempic (semaglutide) for preventing progression of kidney impairment and risk of kidney and cardiovascular mortality in people with Type 2 diabetes and chronic kidney disease (CKD). The submission will be based on data from the kidney outcomes trial FLOW. Currently, Ozempic is approved as an adjunct to diet and exercise for improving glycemic control in adults with Type 2 diabetes and for reducing the risk of major adverse cardiovascular events in adults with Type 2 diabetes and established cardiovascular disease.

FLOW was stopped early in October due to positive efficacy results as recommended by an independent monitoring committee. A new company press release says the trial demonstrated a “statistically significant and superior reduction in kidney disease progression as well as cardiovascular and kidney death of 24% for people treated with semaglutide 1.0 mg compared to placebo. The combined primary endpoint included five components measuring the progression of CKD and the risk of kidney and cardiovascular mortality. Both CKD and cardiovascular components of the primary endpoint contributed to the risk reduction. Further, superiority of semaglutide 1 mg vs placebo was confirmed for the confirmatory secondary endpoints.”

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