Eisai and Biogen said their Alzheimer’s drug slowed cognitive decline in a widely-anticipated study with early signs of the disease, the companies reported Tuesday.
The study, led by Eisai, which has teamed with Biogen to develop the drug called lecanemab, showed the drug targeting amyloid beta in the brains of study participants slowed memory and thinking problems.
Eisai officials said the new study recruited 1,795 people with earlier Alzheimer’s disease and amyloid beta in the brain. Participants received either a 10 mg dose every two weeks over 18 months or a placebo.
The study reported the drug reduced cognitive decline by 27% in people who received the drug compared to placebo.
People on the medication experienced side effects such as brain swelling and tiny bleeds common with the class of amyloid-targeting drugs. The study reported that 17% of people experienced small brain bleeds, compared to 8.7% in the placebo group. The symptoms were detected in brain images but rarely caused symptoms.
The companies already submitted an application to FDA for accelerated approval of the drug based on a smaller, earlier-stage clinical trial. Eisai officials said they will now submit the new trial results to the FDA to bolster its case that lecanemab should be approved as an Alzheimer’s treatment.
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“Today’s announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease, and provide a clinically meaningful impact on cognition and function,” said Michel Vounatsos, Chief Executive Officer at Biogen.
The companies reported the clinical trial results early Wednesday morning in Japan. More detailed findings about the late-stage study will be presented on Nov. 29 at the Clinical Trials of Alzheimer’s Disease Conference in San Francisco.
The study is the latest test to a three decade-old theory that Alzheimer’s disease is triggered by amyloid beta plaques in patients’ brains and can be slowed by drugs that target the buildup of those plaques.
Drug companies have struggled through a long list of failed clinical trials with amyloid-targeting drugs. Biogen’s Aduhelm became the first new Alzheimer’s drug to gain FDA approval last year. It was controversial because it was based on two studies that yielded mixed results.
The FDA’s outside expert advisers recommended against approval, and when the agency approved the drug anyway, three advisers quit in protest.
Biogen and other drug companies seeking FDA approval for a class of Alzheimer’s drugs known as monoclonal antibodies all would fall under Medicare’s decision to pay for the drugs only in clinical trials.
Medicare’s decision to limit payments to drugs in clinical trials followed the FDA’s accelerated approval last year of Biogen’s Aduhelm. The approval was controversial because it was based on two studies that ended prematurely and yielded mixed results.
The FDA’s outside expert advisers recommended against approval, and when the agency approved the drug anyway, three advisers quit in protest.
The companies will present more detailed findings about the late-stage study on Nov. 29 at the Clinical Trials of Alzheimer’s Disease Conference in San Francisco.
