Biogen
says Aduhelm lowers levels of second protein associated with Alzheimer's
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[November 12, 2021]
By Deena Beasley
(Reuters) - Biogen Inc's Alzheimer's drug
Aduhelm, approved by U.S. regulators last year for its ability to reduce
amyloid brain plaques, also lowers levels of a second protein that
accumulates in the brains of people with the disease, according to new
data released by the company on Thursday.
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Biogen said its Phase III studies found that Aduhelm significantly
lowered blood levels of an abnormal form of the protein tau -
another target of experimental Alzheimer's drugs - that forms toxic
tangles of nerve fibers associated with the mind-wasting disease.
The tau levels were correlated to changes in amyloid plaques and
with slowing of cognitive and functional decline, the company said.
In one trial, tau levels in patients with early Alzheimer's given
the highest dose of Aduhelm fell 13%, compared with an increase of
8% for placebo patients. In the second trial, high-dose patients saw
tau levels decrease 16%, while levels in the placebo group rose 9%.
“We now have robust and concordant data that Aduhelm has effect on
two core defining pathologies of Alzheimer’s disease," Biogen
research chief Alfred Sandrock said in a statement.
The findings were presented on Thursday at the Clinical Trials on
Alzheimer’s Disease conference held virtually and in Boston.
![](http://archives.lincolndailynews.com/2021/Nov/12/images/ads/current/farmers_bank_sda_FHI_2021.png)
Since brain changes associated with Alzheimer's, including amyloid
and tau deposits, begin years before cognitive decline can be
identified, drug development in recent years has focused on early
treatment that can interfere with underlying changes believed to
lead to the disease.
Only one of Biogen's two pivotal trials showed Aduhelm can slow the
rate of cognitive decline for Alzheimer's patients. Many experts
have questioned the Food and Drug Administration's rationale for
approving the drug without more definitive proof of benefit.
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![](http://archives.lincolndailynews.com/2021/Nov/12/images/ads/current/countryfinancial_lda_PPP_2018.png) The FDA has defended its
decision by saying there is clear evidence that
Aduhelm removes amyloid from the brains of
people with Alzheimer’s, arguing that the effect
is reasonably likely to predict a clinical
benefit to patients. Some
members of an advisory panel to the FDA resigned in protest and
several prominent treatment centers have publicly said they will not
offer Aduhelm to patients. The new data shows that
when the drug clears amyloid plaques it then impacts markers of
neurologic degeneration, leading to improvements in clinical
outcomes, Biogen Chief Medical Officer Maha Radhakrishnan said in an
interview.
Early sales of Aduhelm, priced at $56,000-a-year, have been slow.
Third-quarter sales of $300,000 were far below the nearly $11
million Wall Street had expected. Medicare, the government's health
plan for people over age 65, expects to issue a draft decision on
its reimbursement policy - which will apply to all plaque-reducing
agents - in January, with a final policy due in April.
In 2020, an estimated 5.8 million Americans aged 65 years or older
had Alzheimer’s disease, according to the U.S. Centers for Disease
Control and Prevention. This number is projected to nearly triple to
14 million people by 2060.
(Reporting By Deena Beasley; Editing by Bill Berkrot)
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