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- Kisunla - ALZFORUM
Background Donanemab, aka N3pG, is a humanized IgG1 monoclonal antibody developed from mouse mE8-IgG2a This biologic drug recognizes Aβ (p3-42), a pyroglutamate form of Aβ that is aggregated in amyloid plaques Most Aβ antibodies in therapeutic development bind various soluble or insoluble species but have low affinity to deposited amyloid plaques The rationale behind donanemab is that
- And Then There Were Three: Donanemab Phase 3 Trial Positive
The donanemab Phase 3 trial is a major accomplishment on many levels: its unequivocal success in demonstrating clinical benefit, the fact that Lilly was able to conduct and complete a very large Phase 3 trial within two years of reporting the Phase 2 story, and the success using tau PET to enroll people with the biological profile most likely
- Questions, Questions for Donanemab, Lecanemab | ALZFORUM
Donanemab is being trialed in the Colombian kindred, Down’s syndrome Baseline plaque load best predicts amyloid clearance on donanemab The fluid biomarker MTBR-243 tau tracks tangle response to lecanemab The relationship between plaque clearance and cognition is fuzzy
- Fully Loaded: Secondary Prevention Studies of Lecanemab, Donanemab
Unlike donanemab, remternetug has been designed to be injected under the skin (Apr 2023 conference news) In Madrid, Kevin Biglan at Lilly described a new, global Phase 3 trial, Trailrunner-Alz3 Enrollment began in October, with a goal of recruiting 1,200 people between 55 and 80 who have preclinical AD or mild cognitive impairment
- Donanemab Clinical Use Growing in U. S. , Rejected in Europe
Like lecanemab before it, donanemab’s path to market has been slow and rocky In the U S , the antibody received Food and Drug Administration approval about nine months ago, but only a few hundred people are on it yet In Europe, the Committee for Medicinal Products for Human Use on Thursday
- Donanemab Approved in the U. S. - ALZFORUM
Donanemab has become the second anti-amyloid immunotherapy to win traditional approval from the U S Food and Drug Administration The antibody, which will be marketed as Kisunla, got the official go-ahead July 2 The decision had been widely expected after the agency’s advisory committee voted
- Donanemab: Small Tweak in Titration, Big Gain in Safety?
When donanemab was titrated up in steps, ARIA-E risk dropped For APOE4 homozygotes, risk fell to nearly the level in heterozygotes New donanemab AUR are stricter than the label, emphasizing safety
- Donanemab Approval Likely to Pose New Quandaries for Clinicians
Donanemab has also been shown to clear plaque by stimulating microglia to gobble it up How to Minimize Risk? As with other antRi-amyloid antibodies, safety was a major concern Donanemab produces about twice as much ARIA-E as does lecanemab, with edema in a quarter of patients About a fourth of them, i e , 6 percent of all patients, develop
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