Drugs

FDA OKs New Lilly Alzheimer’s Drug

FDA has approved Lilly’s Kisunla (donanemab-azbt) injection to treat Alzheimer’s disease. An agency statement says treatment with Kisunla should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which the drug was studied in clinical trials.

Kisunla is administered as an injection every four weeks. Its efficacy was evaluated in a parallel-group study of patients with Alzheimer’s disease. FDA says patients treated with Kisunla demonstrated a statistically significant reduction in clinical decline.

The drug’s labeling includes a Boxed Warning for amyloid-related imaging abnormalities (ARIA), which most commonly presents as temporary swelling in areas of the brain that usually resolve over time and may be accompanied by small spots of bleeding in or on the surface of the brain, FDA says. The agency says the most common Kisunla side effects were ARIA and headache.

FDA granted the Lilly application fast track, priority review, and breakthrough therapy designations.

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