Pharmaceutical companies Biogen and Eisai said on September 27 that a drug they
are developing for
Alzheimer’s disease had slowed the rate of cognitive decline
in a large late-stage clinical trial.
The
strong results boost the drug’s chances of winning approval and offer renewed
hope for a class of Alzheimer’s drugs that have repeatedly failed or generated
mixed results.
The positive
data also offer Biogen a second chance after the company’s disastrous rollout
of another Alzheimer’s drug, Aduhelm. That medication won regulatory approval
last year despite little evidence that it could slow cognitive decline,
received only sharply limited coverage by Medicare, and has proved to be a
commercial failure.
The
results appear stronger for the new medication, lecanemab. Cognitive decline in
the group of volunteers who received lecanemab was reduced by 27 percent compared
with the group who received a placebo in the clinical trial, which enrolled
nearly 1,800 participants with mild cognitive impairment or mild Alzheimer’s
disease, the companies said.
The
trial of lecanemab, which is administered via intravenous infusion, was the
largest to date to test whether clearing the brain of plaques formed by the
accumulation of a protein called amyloid could slow the progression of
Alzheimer’s disease. Aduhelm is designed to work in a similar way.
As with
previous anti-amyloid drugs, some patients taking lecanemab experienced brain
swelling or brain bleeding, but the prevalence of these side effects was lower
than with Aduhelm and other experimental medications.
Eisai
had already applied for accelerated approval, the type of approval given to
Aduhelm. The process allows the
Food and Drug Administration to greenlight
drugs if they have uncertain evidence of benefit but affect a disease’s
biological pathway in a way that is considered reasonably likely to benefit
patients. The company said that it would first continue with the accelerated
approval process, with an FDA decision expected by early January, and then use
the newer data to seek full approval. (Accelerated approval requires companies
to do further trials and prove that their drug works.)
Analysts
predict that lecanemab, or any effective Alzheimer’s medication, would most
likely be a multibillion-dollar blockbuster.
“For
Biogen, it puts them back in the Alzheimer’s game,” said Brian Skorney, an
analyst at the investment bank Baird.
In a
briefing for reporters on September 27, Ivan Cheung, the chairman and CEO of
Eisai, said the results represented “the first definitively positive large
clinical trial to show that you can indeed slow down Alzheimer’s disease at
this very early symptomatic stage”.
He said
that the drug started to show a benefit to patients about six months after they
began taking it and that the benefit increased until the trial ended, 18 months
after patients started on the drug.
The
companies plan to present more detailed results in November.
Some
experts said the drug’s ability to slow cognitive decline — by 0.45 on an
18-point scale — was modest at best and might not be a difference that patients
in the mild early stages of the disease would notice.
Dr Lon
Schneider, director of the California Alzheimer’s Disease Center at the
University of Southern California, said the effect “is small and would not be
considered by many as a minimally clinically important difference”. However, he
added, “others would strongly disagree and say it’s clinically meaningful.”
Schneider
said the “relatively low” rates of brain swelling and bleeding “suggest that
lecanemab is easier to use” than Aduhelm.
He
added that “although taking a press release at face value, which is often a
chancy thing to do without having real data or reports, it seems that lecanemab
would most likely receive regular marketing approval based on this one study
alone”.
In the
briefing, Cheung said the company considered the results “very clinically
meaningful”, but he added, “Of course, there are different opinions out there
on defining what clinical meaningfulness is for this stage of disease”.
Other
companies are also developing treatments that could shake up the market for
Alzheimer’s drugs, which, before Aduhelm, had not seen a novel treatment for
two decades. Before the end of this year, Roche is expected to report data from
two studies of a drug known as gantenerumab. The US FDA is expected to make a
decision on whether to grant accelerated approval to an Alzheimer’s drug from
Eli Lilly known as donanemab by early January, with results from a larger study
of that drug due in the middle of next year.
The
results from the study on lecanemab “set a high bar that I think will be hard
for the other drugs, if they are successful, to beat”, Skorney said.
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