CHICAGO, July 30 (Reuters) - The benefit of Eisai ( ESALF )
and Biogen's Alzheimer's drug Leqembi in
patients with early-stage Alzheimer's appears to increase with
continued use with no new safety issues, according to three-year
data presented at an Alzheimer's meeting on Tuesday.
In the companies' pivotal clinical trial, Leqembi reduced
cognitive decline by 27% after 18 months - data that supported
the drug's approval last year.
The new study looked at how the drug performed in about 95%
of trial patients who continued on the treatment. After three
years, Leqembi slowed cognitive decline by 31% compared to what
would be expected in similar patients who did not receive
treatment.
There were no new safety findings over the three-year
period. Brain swelling and bleeding associated with drugs that
work by removing amyloid plaque from the brain largely occurred
within the first six months of treatment, Dr. Christopher van
Dyck, director of the Yale's Alzheimer's Disease Research Unit,
told the meeting.
A separate analysis of data from a midstage study looked at
patients who had a gap in treatment of 9 to 59 months following
18 months of initial treatment. In that study, there was still a
difference, but once treatment stopped, the rate of cognitive
decline reverted back to what was seen in patients on placebo.
Discontinuation of treatment also showed increases in
Alzheimer's-related disease biomarkers, such as the return of
amyloid plaques.
The findings were part of several presentations at the
Alzheimer's Association International Conference in Philadelphia
aimed at showing that Eisai's ( ESALF ) drug continues to benefit patients
who stay on Leqembi after amyloid has been removed.
Eisai's ( ESALF ) drug targets protofibrils - toxic building blocks
that eventually form clumps in the brain known as amyloid
plaques, a hallmark of Alzheimer's disease. Leqembi both removes
amyloid plaques and continues to target protofibrils, which can
injure brain cells.
"There is no question long-term benefit is better than
short-term benefit," Dr. Lynn Kramer, Eisai's ( ESALF ) chief clinical
officer, told Reuters.
The studies underline differences between Eisai ( ESALF ) and Biogen's
treatment and Eli Lilly's ( LLY ) Alzheimer's drug Kisunla
(donanemab), which was approved on July 2.
The Lilly drug exclusively targets amyloid plaques. Once the
brain plaque is gone, patients can discontinue treatment.