FDA delays approval of Alzheimer’s drug donanemab:
On Friday, Eli Lilly declared that the U.S.S. committee headed by the Food and Drug Administration (FDA) was formed to assess donanemab, the Alzheimer’s medication whose approval was halted last year. Before the FDA decides whether to approve donanemab, the committee is anticipated to meet later this year. For many, though, the announcement is surprising. Donanemab significantly slowed the clinical progression of early Alzheimer’s patients in a trial conducted last year, but it also caused brain swelling and other side effects. Here are the opinions of experts on what this decision means for patients with Alzheimer’s disease. Lecanemab (Leqembi) and aducanumab (Aduhelm) are two of the three monoclonal antibody treatments for Alzheimer’s that include donanemab. Although there was little proof in the early trials that removing the amyloid plaques associated with Alzheimer’s disease slowed cognitive decline, all three medications function by doing so.
Over 55 million people worldwide suffer from dementia, and up to 70 percent of those cases are Alzheimer’s disease, which is defined by an accumulation of the proteins tau and amyloid. The U.S. approved aducanumab and lecanemab with accelerated approval. S. FDA, in response to encouraging clinical outcomes. As they were doing their due diligence on the medication, I believe they discovered a few aspects about it about which they wanted to form an advisory committee—basically, three things. There was a slight improvement in efficacy along with a slight rise in the safety signal. Donanemab had a very special, constrained dosing schedule regimen, with significant implications for clinical care. Additionally, tau imaging was utilized to gain entry into the trial. However, there was a question as to whether or not tau imaging would be required for clinical use in the real world and if it would be on the label. He clarified that careful monitoring would be necessary in the early stages of treatment, with MRIs performed in the first three to five months while possibly searching for ARIA or other indications that the drug should be stopped.
If they do occur, the drug is essentially stopped for a while, then the transfusion is resumed and stopped again for a while. However, in the case of homozygote APOE ε4 individuals who have two APOE ε4s and experience brain bleeding, hemorrhage, or edema as a result of the ARIA side effects, they may simply be stopped and not resumed, depending on the severity of those MRI findings. However, he feels that the risks are too great for him to suggest donanemab or any comparable medication. I do not think medications like donanemab are useful therapies for patients with Alzheimer’s dementia, as a clinical neurologist who treats and diagnoses patients with dementia. The risks of brain edema and bleeds associated with these medications outweigh their benefits. Like a lot of neurologists working in clinical practice, I refuse to take any drugs from [this] family. In the past, neurologists sold amyloid medications as a means of treating neuropathy symptoms; however, these drugs are no longer in use. I hope that the FDA’s decision to revoke Donanemab’s application is just one more step toward the discontinuation of [this] class of drugs.
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