INDIANAPOLIS, March 8,
2024 /PRNewswire/ -- Eli Lilly and Company (NYSE:
LLY) today announced that the U.S. Food and Drug Administration
(FDA) expects to convene a meeting of the Peripheral and Central
Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase
3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety
of donanemab in early symptomatic Alzheimer's disease.
The FDA has informed Lilly it wants to further understand topics
related to evaluating the safety and efficacy of donanemab,
including the safety results in donanemab-treated patients and the
efficacy implications of the unique trial design of the
TRAILBLAZER-ALZ 2 study, including its limited-duration dosing
regimen that allowed patients to complete treatment based on an
assessment of amyloid plaque and the inclusion of participants
based on tau levels.
The date of the advisory committee meeting for donanemab has yet
to be set by the FDA, and, as a result, the timing of expected
FDA action on donanemab will be delayed beyond the first quarter of
2024. While it is unusual for an advisory committee to occur after
the anticipated FDA action date, the advisory committee meeting for
donanemab follows similar meetings for the two other amyloid
plaque-targeting therapies the FDA has approved.
"We are confident in donanemab's potential to offer very
meaningful benefits to people with early symptomatic Alzheimer's
disease. It was unexpected to learn the FDA will convene an
advisory committee at this stage in the review process, but we look
forward to the opportunity to further present the TRAILBLAZER-ALZ 2
results and put donanemab's strong efficacy in the context of
safety. We will work with the FDA and the stakeholders in the
community to make that presentation and answer all questions," said
Anne White, executive vice president
of Eli Lilly and Company, and president of Lilly Neuroscience.
TRAILBLAZER-ALZ 2 is a Phase 3, double-blind, placebo-controlled
study to evaluate the safety and efficacy of donanemab in
participants ages 60-85 years with early symptomatic Alzheimer's
disease (MCI or mild dementia due to Alzheimer's disease) with the
presence of confirmed Alzheimer's disease neuropathology.
Alzheimer's disease is a progressive and fatal disease that in its
early symptomatic stages affects 6-7.5 million Americans. The trial
enrolled 1,736 participants, across eight countries, selected based
on cognitive assessments in conjunction with amyloid plaque imaging
and tau staging by positron emission tomography (PET) imaging.
Compared to participants in similar trials of other amyloid
plaque-targeting therapies, the TRAILBLAZER-ALZ 2 participants were
more progressed in their disease. All groups of trial participants,
regardless of tau level, benefited from treatment with donanemab,
with patients in earlier stages of the disease experiencing the
strongest results. Donanemab also demonstrated clinical benefits
using a limited-duration treatment regimen, with nearly half of
clinical trial participants completing their course of treatment in
six or 12 months. The key risk associated with donanemab is
amyloid related imaging abnormalities, or ARIA, which can be
serious and life-threatening. Other most commonly reported risks
include infusion-related reactions, headache and nausea.
The Phase 3 TRAILBLAZER-ALZ 2 study results were published in
the Journal of the American Medical Association (JAMA).
Lilly continues to study donanemab in multiple clinical trials.
This action does not result in a change to Lilly's 2024
financial guidance.
About Lilly
Lilly is a medicine company turning
science into healing to make life better for people around the
world. We've been pioneering life-changing discoveries for nearly
150 years, and today our medicines help more than 51 million people
across the globe. Harnessing the power of biotechnology, chemistry
and genetic medicine, our scientists are urgently advancing new
discoveries to solve some of the world's most significant health
challenges: redefining diabetes care; treating obesity and
curtailing its most devastating long-term effects; advancing the
fight against Alzheimer's disease; providing solutions to some of
the most debilitating immune system disorders; and transforming the
most difficult-to-treat cancers into manageable diseases. With each
step toward a healthier world, we're motivated by one thing: making
life better for millions more people. That includes delivering
innovative clinical trials that reflect the diversity of our world
and working to ensure our medicines are accessible and affordable.
To learn more, visit Lilly.com and Lilly.com/news, or follow
us on Facebook, Instagram and LinkedIn. P-LLY
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking
statements (as that term is defined in the Private Securities
Litigation Reform Act of 1995) about donanemab as a potential
treatment for people with early symptomatic Alzheimer's disease and
reflects Lilly's current beliefs and expectations. However, as with
any such undertaking, there are substantial risks and uncertainties
in the process of drug research, development, and
commercialization. Among other things, there is no guarantee that
future study results will be consistent with study findings to
date, that donanemab will prove to be a safe and effective
treatment, or that donanemab will receive regulatory approval. For
further discussion of these and other risks and uncertainties, see
Lilly's Form 10-K and Form 10-Q filings with the United States
Securities and Exchange Commission. Except as required by law,
Lilly undertakes no duty to update forward-looking statements to
reflect events after the date of this release.
Refer to: J.K. Wall; jkwall@lilly.com; 317-433-5328
(Media)
Joe
Fletcher; jfletcher@lilly.com; 317-296-2884 (Investors)
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SOURCE Eli Lilly and Company