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 The Biogen/Eisai drug Aduhelm was the first Alzheimer's treatment to
win approval in nearly 20 years, but the Food and Drug
Administration's (FDA) controversial use of the accelerated approval
process - which authorizes drugs for severe conditions without
strong proof of a benefit to patients - has come under heavy fire.
Biogen and Eisai won authorization for Aduhelm based on evidence
that it can reduce brain plaques, a likely contributor to
Alzheimer's, rather than convincing proof that it slows progression
of the lethal disease. Companies are required to run confirmatory
studies to prove the drug works as intended.
Now, Eisai, which leads development on Alzheimer's drug lecanemab,
is using evidence from a midstage trial showing its drug candidate
removes brain plaques to an even greater degree than Aduhelm, with
lower rates of brain swelling.
Eisai intends to learn from its partner's experiences as it works
through the regulatory process. Ivan Cheung, president of Eisai's
global neurology group, said in an interview the company is being as
transparent as possible.
Eisai will submit its application to the FDA on a rolling basis,
with the aim of completing the application in the next few months.
The company plans to submit data from its midstage trial of 856
volunteers, which showed that 80% of patients had no amyloid left in
their brains after 18 months of treatment.
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 That benefit also correlated
with improvements seen in some patients, Cheung
said. The trial was published in Alzheimer's
Research and Therapy, a peer-reviewed journal,
in April. A key point of
contention with the Aduhelm approval is the timing of the
confirmatory trial, which FDA officials said could take several
years. Eisai already has a confirmatory, Phase III trial fully
enrolled. Cheung expects results before the end of 2022.
"We understand the urgency for the public to have validating
clinical data," Cheung said.
The FDA initially gave Aduhelm a broad indication that went beyond
what was studied in its trials. Cheung said his company only wants
the FDA to consider the drug's exact study population - early
Alzheimer's.
Eli Lilly and Co said in July it also plans to seek accelerated
approval for its Alzheimer's candidate, donanemab, based on
mid-stage data. Lilly has said it plans to seek U.S. regulatory
approval by yearend.
(Reporting by Julie Steenhuysen; Editing by Aurora Ellis)
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