Drugs

Novo Nordisk’s Alzheimer’s Hopes Face Set Back

Novo Nordisk says data from two global Phase 3 trials, evoke and evoke+, of semaglutide (Ozempic and Wegovy) have failed to slow clinical progression in adults with early-stage symptomatic Alzheimer’s disease over two years. The trials enrolled 3,808 people aged 55 to 85 with mild cognitive impairment or mild dementia due to Alzheimer’s, all with confirmed amyloid positivity, according to the company.

While semaglutide improved several Alzheimer’s-related biomarkers — an early indicator of potential biological activity — those changes did not translate into clinical benefit, as measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB), the primary endpoint, Novo Nordisk says.

Novo Nordisk had acknowledged before launching the studies that the program carried a low likelihood of success. Interest in GLP-1 agonists as potential Alzheimer’s therapies surged in recent years, driven by real-world evidence studies suggesting reduced dementia risk among users, as well as post-hoc signals observed in diabetes and obesity trials. Several academic groups and companies have been investigating the possibility that GLP-1–based drugs may reduce neuroinflammation or improve vascular health.

“Based on the significant unmet need in Alzheimer’s disease as well as a number of indicative data points, we felt we had a responsibility to explore semaglutide’s potential,” a company release says. “While semaglutide did not demonstrate efficacy in slowing the progression of Alzheimer’s disease, the extensive body of evidence supporting semaglutide continues to provide benefits for individuals with Type 2 diabetes, obesity, and related comorbidities.”

Novo Nordisk says it will present the top-line data at the Clinical Trials on Alzheimer’s Disease meeting on 12/3, with full data expected in 3/2026.

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