Drugs

FDA Reviewers Air Alzheimer’s Drug Issues

An FDA briefing document released in advance of a 6/10 meeting of the agency’s Peripheral and Central Nervous System Advisory Committee raises some issues about the safety and effectiveness of Lilly’s donanemab-azbt to treat Alzheimer’s disease. The document says the company’s 6/12/2023 BLA was based on results from the TRAILBLAZER-ALZ 2 trial that evaluated the safety and efficacy of donanemab in patients with early symptomatic Alzheimer’s disease.

The FDA medical reviewers say the primary efficacy endpoint analysis demonstrated a statistically significant treatment effect in the donanemab treatment arm compared to placebo. They say the main safety signals associated with the use of monoclonal antibodies directed against aggregated forms of beta amyloid, including donanemab, are amyloid-related imaging abnormalities, intracerebral hemorrhage, and infusion-related reactions and hypersensitivity.

FDA is asking committee members whether the efficacy data establish the clinical benefit of donanemab in treating Alzheimer’s disease and whether the benefit/risk assessment supports approving the drug. The specific points for consideration are:

whether the available data provide evidence of effectiveness of donanemab for the treatment of Alzheimer’s disease;
the dosing regimen used in the clinical studies that completed treatment based on reduction of amyloid plaques on PET imaging; and
the overall benefit/risk assessment of donanemab for treating Alzheimer’s 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

Read more

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