Leqembi - ALZFORUM
On January 6, 2023, the FDA approved lecanemab under the Accelerated Approval pathway, based on evidence of effect on the surrogate endpoint of amyloid removal in the Phase 2 trial, and a reasonable likelihood of clinical benefit (FDA press release; Jan 2023 news). Lecanemab is sold under the brand name Leqembi.
Finally: Big Win on All Outcomes for Lecanemab in Phase 3
Oct 12, 2022 · 28 Sep 2022. Eisai and Biogen yesterday announced positive topline results from the Phase 3 Clarity trial of their anti-amyloid antibody lecanemab. The drug slowed decline on the primary endpoint, CDR-SB, by 27 percent over 18 months, and also nudged down decline on all secondary clinical endpoints. The incidence of the brain edema known as ...
Lecanemab Bested Three Other Antibodies at Binding Soluble Aβ ...
Lecanemab also binds to fibrils, which comprise amyloid plaques, but with a 10-fold greater affinity for protofibrils relative to fibrils (Soderberg et al., 2023). Fertan et al. describe the binding profile using a SiMoA assay, mimicking aggregates. Lecanemab showed strongest binding to soluble Aβ42 aggregates.
Rising Leqembi Prescriptions Are Straining Clinic Capacity
Scans can run up to $6,000 and, as of October, started being covered by CMS (Oct 2023 community news). This announcement sparked another surge in demand for lecanemab. “Before, people opted out [of treatment] for that reason,” Russell Swerdlow of Kansas University Medical Center in Kansas City told Alzforum.
Lecanemab Follows Aduhelm’s Path to Accelerated Approval
Oct 20, 2021 · Eisai/Biogen are already on that path with lecanemab, having applied to the FDA for a marketing license on September 27. Unlike with aducanumab, the companies filed directly under the accelerated-approval pathway, using Phase 2b data that show drastic plaque reduction. Eli Lilly is expected to follow suit later this year with donanemab.
Dare We Say Consensus Achieved: Lecanemab Slows the Disease
Dec 9, 2022 · Overall, lecanemab appeared to slow disease progression by about one-quarter, and caused the brain edema known as ARIA-E in one of eight participants. The data were published in the New England Journal of Medicine November 29, …
Lecanemab: FDA Set Accelerated Approval Decision for January 2023
Jul 7, 2022 · This means the agency will make a final decision within six months, by January 6, 2023. Lecanemab, aka BAN2401, follows the path established by aducanumab, which received accelerated approval last year (Jun 2021 news). On the heels of that approval, the FDA granted lecanemab breakthrough therapy status, a designation that speeds the regulatory ...
Lecanemab Sweeps Up Toxic Aβ Protofibrils, Catches Eyes of Trialists
Nov 26, 2021 · Lecanemab differs from other antibodies in late-stage trials in that it was generated against synthetic Aβ protofibrils (Apr 2011 news). Protofibrils are large, soluble, β-sheet aggregates between 75 and 500 kD in size that are a major source of amyloid toxicity (Sehlin et al., 2012). By contrast, aducanumab was derived from the natural ...
U.S. FDA Gives Green Light to Leqembi, aka Lecanemab
Tools. 06 Jan 2023. The Food and Drug Administration today approved Eisai’s anti-amyloid antibody lecanemab, now called Leqembi, via its accelerated approval pathway. The decision was widely expected based on the positive Phase 2 and 3 results for lecanemab, and because of a similar accelerated approval previously for aducanumab in 2021 (Jun ...
And Then There Were Three: Donanemab Phase 3 Trial Positive
Posted: 05 May 2023. The donanemab Phase 3 outcomes—according to Lilly’s press release—are remarkably like its Phase 2 trial outcomes and the Clarity-AD lecanemab Phase 3 trial. The iADRS mean differences were approximately 3.26 in the targeted intermediate tau group and 2.88 in the combined intermediate/high tau group.