Lilly Drug Slows Alzheimer's Progression by 35 Percent
An experimental Alzheimer's drug developed by Eli Lilly and Co slowed
cognitive decline by 35% in a closely watched late-stage trial, the
company said on Wednesday, raising hopes for a second effective
treatment for the brain-wasting disease.
The drug, donanemab, met all primary and secondary goals of the
trial. It slowed progression of Alzheimer's by 35% to 36% compared to a
placebo in 1,182 people diagnosed with early-stage disease based on
scans showing brain deposits of a protein called amyloid and
intermediate levels of a second protein known as tau, Lilly said. The
trial's other 552 patients had high levels of tau, suggesting they would
be less likely to respond to the treatment.
After combining both groups, donanemab was shown to slow progression of
Alzheimer's by 22% using a Lilly-developed scale to measure cognition
and activities of daily living, and by 29% based on a more commonly used
scale of dementia progression. "These are the strongest phase 3 data
for an Alzheimer's treatment to date. This further underscores the
inflection point we are at for the Alzheimer's field," said Maria
Carrillo, chief science officer for the Alzheimer's Association.
Using the commonly used dementia scale, trial results published last
year showed that Eisai Co Ltd and Biogen Inc's Leqembi reduced the rate
of cognitive decline by 27% compared to a placebo in patients with early
Alzheimer's.
Eli Lilly's shares rose 8.3% to $437.55, while Biogen fell nearly 5% to $293.99 in premarket trading.
In the donanemab treatment group, Lilly said brain swelling, a known
side effect of drugs of this type, occurred in 24% of the participants,
with 6.1% experiencing symptoms. Brain bleeding occurred in 31.4% of the
donanemab group and 13.6% of the placebo group.
In the Leqembi Phase 3 trial, the drug was associated with brain swelling in nearly 13% of its study participants.
Lilly said the incidence of serious brain swelling in the donanemab
study was 1.6%, including two participants whose deaths were attributed
to the condition and a third who died after an incident of serious brain
swelling.
Dr. Eric Reiman, executive director of the Banner Alzheimer's
Institute, which is running an Alzheimer's prevention study of donanemab
in presymptomatic patients, said he was "very excited" about the
findings. "Clearly, one saw benefits here, but there is some risk that
needs to be considered."
The company said it plans to file for traditional U.S. approval by
the end of June and with regulators from other countries shortly
thereafter.
"There are risks in medicine, but I think when you look at these
results in the context of a fatal life-threatening disease, these
results are quite meaningful," said Lilly Neuroscience executive Anne
White in an interview with Reuters.
Study participants received a monthly intravenous infusion of
donanemab. When follow-up brain scans showed that amyloid had been
removed, the treatment was stopped and volunteers were moved to the
placebo-arm of the study. Half of the trial participants had no evidence
of amyloid plaques at 12 months, the company said.
It also said 47% of donanemab patients in the 18-month trial had no
disease progression at 12 months, compared with 29% of the placebo
group.
Lilly's drug is likely to become the third in its class on the market
following U.S. approval of two similar medicines developed by partners
Eisai and Biogen - Leqembi and Aduhelm, which failed to gain traction
with doctors or insurers after showing little evidence that they slowed
cognitive decline.
Both were approved under the FDA's accelerated review program, based on their ability to remove amyloid plaques.
Leqembi is currently undergoing the FDA's standard review process,
which will weigh its impact on cognitive function, with a decision due
by July 6. More than 6 million Americans are living with Alzheimer's,
and the number is projected to rise to nearly 13 million by 2050,
according to the Alzheimer's Association.
