The trial results bring good news for anti-amyloid therapy. Anti-amyloid therapy is a drug class that has been plagued by controversy and confusing data. But this study showed why safety concerns swirl around the drug. I believe there is. These complications, called ARIA, usually involve swelling and bleeding in the brain. A third participant died after experiencing a serious incident of ARIA, but investigators did not link the death to ARIA. Lily said she could neither attribute the death to ARIA nor rule it out.
The donanemab trial, which included about 1,700 people with early symptoms of Alzheimer’s disease, is the latest evidence that anti-amyloid drugs “are not without risks” and will require debate between doctors and patients. , Mayo Clinic in Rochester, Minnesota.
Nonetheless, donanemab’s ability to slow cognitive and functional decline indicates that “we are on the right track” in pursuing anti-amyloid therapy. Results from other studies, including therapeutic agents, show that lowering amyloid levels in the brain may “slow the clinical progression of the disease, resulting in modest effects rather than large effects.” “If we can keep these individuals functioning, we should consider it.”
Donanemab is given intravenously once a month.
Indianapolis-based Lilly, which announced the results in a news release Wednesday, said donanemab slowed the decline in participants by 35% over 18 months. and talk about current events. The company said it plans to apply for FDA approval by the end of June.
The data have not been peer-reviewed. Lilly said she plans to submit this information to a peer-reviewed journal.
The 35% slowdown occurred in a group with moderate levels of a protein called tau in the brain, which is also associated with Alzheimer’s disease. The drug slowed the decline by 22% when all participants with high levels of tau were considered.
Within the group that showed a 35% slowdown in deterioration over 18 months, 47% of participants showed no deterioration after 1 year compared to 29% in the placebo group.
In addition, 52% of participants were able to discontinue treatment after 1 year, and nearly three-quarters discontinued treatment after 18 months, as scans showed that amyloid plaques were effectively cleared from the brain. .
Some doctors weren’t enthusiastic.
“Safety is the real issue with this class of drugs,” says Robert Howard, a psychiatrist at University College London. Said on Twitter. “At the moment, few people are talking about it, but if we see a significant number of patient deaths in clinics, it will all be over.” I wondered if that family would be big enough to notice.
In January, the FDA rejected Lilly’s bid for early approval of donanemab, citing the need for more patient safety data.
If federal regulators approve donanemab, two anti-amyloid drugs could hit the market by the end of this year or early next year. In January, the FDA granted expedited approval to a similar drug called Leqembi by Eisai and Biogen. is applying for
Another Biogen drug called Aduhelm received accelerated approval from the FDA in June 2021.
