Eli Lilly Alzheimer's Programs Head in Different Directions
By Colin Kellaher
Eli Lilly & Co. on Tuesday said it is moving forward with a
its most promising Alzheimer's disease drug but pulling the plug on
another program targeting the memory-loss disease.
The Indianapolis drug maker said it initiated a rolling
submission with the U.S. Food and Drug Administration for
donanemab, seeking accelerated approval for the drug in early
The move comes after the FDA earlier this year gave an
accelerated green light to Biogen Inc.'s Aduhelm, the first new
Alzheimer's drug in nearly two decades.
Like Aduhelm, Lilly's donanemab is aimed at reducing a sticky
protein called amyloid in the brain. The FDA based its approval of
Biogen's drug on the likelihood that reducing amyloid would result
in a slowing of cognitive decline, though the agency acknowledged
that the benefit was uncertain.
The FDA last month granted breakthrough-therapy designation to
donanemab, which is currently in Phase 3 studies. The designation
aims to expedite the development and review of a drug for serious
conditions when preliminary clinical evidence shows the drug may
show substantial improvement over available therapies.
Eli Lilly on Tuesday said it plans to conduct a Phase 3
head-to-head clinical study comparing donanemab to Aduhelm to
assess superiority of brain amyloid plaque clearance in early
symptomatic Alzheimer's disease, with enrollment slated to begin
Analysts at Mizuho said donanemab is one of two key pipeline
assets, along with the diabetes drug candidate tirzepatide, that
are likely to drive growth for Lilly in the coming years.
Still, as Eli Lilly advances its donanemab efforts, the company
said it is ending development of zagotenemab, another Alzheimer's
drug candidate targeting tangles of tau protein in the brain.
The company said zagotenemab didn't meet the primary endpoint in
a Phase 2 study in early symptomatic Alzheimer's and was unable to
modulate tau spread in the brain.
Biogen earlier this year suffered its own setback in its
tau-targeting efforts after its investigational anti-tau antibody
gosuranemab missed its targets in a Phase 2 study, prompting the
Cambridge, Mass., company to end development of the drug.
An Eli Lilly representative said the company remains committed
to tau as a high conviction target in Alzheimer's and plans to
continue studying tau biology, including inhibition of tau
aggregation, with a small molecule O-GlcNAcase inhibitor currently
in the clinic.
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires
October 26, 2021 11:30 ET (15:30 GMT)
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