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 In approving Biogen's Aduhelm over the objection of its own panel of
outside expert advisers, the U.S. Food and Drug Administration has
required a trial to confirm that the medicine will indeed slow
progression of the lethal, mind-wasting disease - a process that
could take several years - even as the drug is being used by
patients.
But data expected much sooner on three drugs that work in a similar
manner - Eli Lilly and Co's donanemab, Roche Holding AG's
gantenerumab, and partners Eisai Co and Biogen's lecanemab - could
give the medical community a better sense of whether Aduhelm is up
to the job of slowing the ravages of Alzheimer's.
Aduhelm was approved last week based on its ability to clear a type
of plaque from the brain that is believed to be a possible cause of
Alzheimer's, rather than evidence that it slows disease progression.
The FDA contends the plaque removal is likely to benefit patients,
an assertion many experts say is unproven.
"I don't feel that we have evidence now that there's a clinical
benefit from reducing amyloid," said Dr. Henry Paulson, a
neurologist who leads the University of Michigan's Alzheimer’s
Disease Center.
"If another independent study of a different anti-amyloid therapy
shows a clear clinical benefit, it makes me much more comfortable
with continued use of Aduhelm," he said.
All four drugs are antibodies aimed at reducing the accumulation of
the sticky plaques composed of a protein called beta amyloid found
in the brains of people with Alzheimer's, a disease that currently
afflicts some six million Americans.
Positive data from the three experimental medicines could also
provide an indication of future competition for Aduhelm, which was
developed in partnership with Eisai and is currently the only drug
that targets an underlying cause of the disease.
Large clinical trials of Aduhelm, known chemically as aducanumab,
produced contradictory data, with one trial failing and another
showing benefit. There was also a potentially serious brain swelling
side effect.
Nevertheless, the FDA approved Aduhelm under its "accelerated
approval" program with the understanding that Biogen would conduct a
post-marking study to demonstrate patient benefit.
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FDA officials said other Alzheimer's drugs will not automatically be
eligible for that program. "We can't say right now whether this will
be a path for other Alzheimer's drugs, or drugs for other
neurodegenerative diseases," Dr. Patrizia Cavazzoni, director of the
FDA's Center for Drug Evaluation and Research, told Reuters.
'PRECEDENT-SETTING'
Critics say the decision does change the landscape for future drugs.
"This is precedent-setting whether the FDA likes it or not," said
Dr. Caleb Alexander, a Johns Hopkins public health professor and one
of the remaining members of the FDA advisory panel that reviewed
Aduhelm. Three members of the panel resigned after the FDA approval.
"That's not to suggest that the next drug that lowers amyloid is a
slam dunk or even gets approved. It may not," he said.
For the near future, Biogen will have the market to itself, but
analysts are watching potential future rivals closely.
"If another drug comes along and maybe doesn't have as many side
effects, or maybe has slightly better data, Biogen's position could
be jeopardized," said Raymond James health policy analyst Chris
Meekins.
Japan's Eisai completed enrollment last month in a pivotal 18-month
study of lecanemab in symptomatic early Alzheimer's patients. The
drug is also being studied in a large trial of people with evidence
of amyloid in their brains who do not yet have symptoms of the
disease.
Roche, which has released limited gantenerumab trial findings, said
it expects to have data next year from two global late-stage studies
of its drug.
Eli Lilly announced encouraging results in March from a mid-stage
study of donanemab and plans to conduct a larger trial.
"I think it is quite likely that if they can replicate those results
it would be approved," said Dr. David Knopman, a neurologist at the
Mayo Clinic in Rochester, who quit FDA's advisory panel in protest
over the Aduhelm approval.
(Reporting by Deena Beasley in Los Angeles and Julie Steenhuysen in
Chicago; Editing by Peter Henderson and Bill Berkrot)
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