Drugs

FDA, Biogen Yield to Critics on Alzheimer’s Label

Faced with mounting criticism concerning Biogen’s controversial approval for its Alzheimer’s therapy Aduhelm (aducanumab), FDA 7/7 approved a narrower product label to limit its indication and usage to disease stages studied in the supporting clinical trials. When the drug was approved last month, critics immediately questioned why FDA approved a broad label for use by any patient with Alzheimer’s despite trial data not showing effectiveness in early- or late-stage patients (see earlier story).

The Institute for Clinical and Economic Review (ICER) criticized the approval, noting that FDA granted approval for treatment of all patients with Alzheimer’s disease despite the fact that the drug has been studied only in patients with mild cognitive impairment and mild dementia. “Trials of other amyloid therapies in later Alzheimer’s disease have all failed,” ICER said. “Thus, there appears to be no evidentiary basis to justify the FDA’s decision to extend the label of aducanumab beyond the study populations.”

The updated label now says: “Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”

A Biogen release had this to say: “Based on our ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label update with the goal to further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval. We are committed to continue to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option.”

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