FDA Decision on Experimental Alzheimer's Drug

FDA Decision on Experimental Alzheimer’s Drug

FDA Decision on Experimental Alzheimer’s Drug: Lecanemab, an experimental medication for dementia, may receive fast approval from the U.S. Food and Drug Administration this week, according to the drug’s manufacturers Eisai and Biogen. Phase 3 study results indicate that lecanemab, one of the earliest experimental dementia medications, has “potential” as an Alzheimer’s disease treatment but has prompted safety concerns due to its link with some serious adverse effects, such as brain swelling and bleeding.

According to the business, the FDA evaluated the medicine and accepted Eisai’s Biologics License Application for lecanemab under the accelerated approval pathway in July. While the drugs are still being investigated in more extensive and prolonged trials, the accelerated approval program enables speedier approval of medications that cure severe diseases and “meet an unmet medical need.”

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Lecanemab is anticipated to receive fast approval from the FDA by January 6, according to Libby Holman, a spokesman for Eisai. Lecanemab will be made available as quickly as feasible if the FDA approves it through the Accelerated Approval Pathway, according to an email from Holman.

By the end of Eisai’s fiscal year 2022, which ends on March 31, 2023, the company plans to submit a Supplemental Biologics License Application for formal approval in the U.S. as soon as possible and marketing authorization applications in Japan and Europe. The FDA is anticipated to respond by January 6, according to Maria Carrillo, the Alzheimer’s Association’s chief science officer.

“We think the FDA should approve based on the excellent results of this treatment’s clinical trials. Lecanemab will give individuals with Alzheimer’s disease who are in their early stages more time to engage in everyday activities and live independently, according to peer-reviewed, published results. Carrillo added that it could take them several months to acknowledge their partner, kids, and grandchildren.

The Centers for Medicare and Medicaid Services should “act fast” to cover the medication, she continued, and “revise its coverage decision that presently prevents access to this treatment.” CMS assesses the safety and efficacy of FDA-approved medicines before deciding whether to cover them.

According to Carrillo, “the Alzheimer’s Association has officially requested that CMS give complete and unrestricted coverage for FDA-approved Alzheimer’s medications. A monoclonal antibody called lecanemab binds to amyloid beta, a characteristic of Alzheimer’s disease but is not a treatment.

Lecanemab “reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months,” according to results from an 18-month Phase 3 clinical trial published in The New England Journal of Medicine in late November. Still, it was also linked to adverse events.

The findings also revealed that 2.9% of trial participants who received a placebo discontinued the study, whereas 6.9% of those who received lecanemab as an intravenous infusion did. Overall, 14% of the lecanemab group and 11.3% of the placebo group experienced significant side events.

The reactions to the intravenous infusions and abnormalities on their MRIs, such as bleeding and swelling in the brain known as amyloid-related imaging abnormalities, or ARIA, which can be fatal, were the most frequent adverse events in the lecanemab group.

While some ARIA sufferers may not exhibit symptoms, the condition can occasionally cause hospitalization or long-term disability. Additionally, individuals who carried the APOE4 gene, which raises the chance of developing Alzheimer’s disease and other dementias, tended to have a higher prevalence of ARIA. APOE4 noncarriers “were quantitatively less common” for ARIA.

The trial’s findings also revealed that approximately 0.7% of lecanemab group participants and 0.8% of placebo group participants passed away, or six in the lecanemab group and seven in the placebo group, respectively.

Even if the FDA grants the speedy medicine approval, it will still be put through additional thorough trials. And the FDA might give conventional consent if those tests show that the medication has a therapeutic benefit. However, the FDA has regulatory processes that could take medicine off the market if the confirmatory trial does not demonstrate effectiveness.

Dr. Richard Isaacson, director of the Alzheimer’s Prevention Clinic in the Center for Brain Health at Florida Atlantic University’s Schmidt College of Medicine, who is not involved in studying lecanemab or it, said: “If and when the FDA approves this drug, it will take clinicians some time to be able to parse out how this drug may or may not be effective in their patients.”

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According to the Alzheimer’s Association, there are currently more than 300 Alzheimer’s treatments undergoing clinical trials. The first case of Alzheimer’s disease was identified in 1906 when a woman with memory loss, linguistic difficulties, and erratic conduct had alterations found in her brain tissue.