'Remarkable' Alzheimer's drug reduces cognitive decline
WASHINGTON
U.S. pharmaceutical giant Eli Lilly on May 3 announced its experimental Alzheimer's drug significantly slowed cognitive and functional decline, results hailed as "remarkable" by experts despite some patients experiencing serious side effects.
In an analysis of nearly 1,200 people in the early stages of the disease, donanemab slowed the progression of symptoms by 35 percent over a period of 18 months compared to placebo.
This was measured by cognition and their ability to carry out daily tasks like managing finances, driving, engaging in hobbies and conversing about current events in a standardized index called the Integrated Alzheimer's Disease Rating Scale (iADRS).
Side effects included temporary swelling in parts of the brain, which occurred in almost a quarter of the treated patients, as well as microhemorrhages that occurred in 31 percent of patients on the treatment arm and 14 percent of patients in the placebo group.
Two participants' deaths were attributed to the side effects, while a third might have also died from the treatment.
Nonetheless, the data was widely praised by independent experts, who said donanemab had the potential, if approved, to significantly improve the lives of people suffering from the most common form of dementia.
The news comes after the U.S. approved another Alzheimer's drug in January, Biogen and Eisai's lecanemab, which slowed the rate of cognitive decline by 27 percent and was also declared a blockbuster by experts.
Biogen and Eisai had also developed aducanumab, known by the trade Aduhelm, which was given US approval in 2021, though that decision was mired in controversy and led to a damning report by Congress.
In addition to severe side effects, Aduhlem's clinical effectiveness was ambiguous, which is so far not the case for the two subsequent drugs.
Lilly said it would rapidly submit its results to the U.S. Food and Drug Administration (FDA) as well as other global regulators.
"We are extremely pleased that donanemab yielded positive clinical results with compelling statistical significance for people with Alzheimer's disease in this trial," said Daniel Skovronsky, Lilly's chief scientific and medical officer, in a statement.
