Kisunla slowed cognitive and functional
decline by up to 35% compared to placebo at 18 months in its
pivotal Phase 3 study and reduced participants' risk of progressing
to the next clinical stage of disease by up to 39%
Kisunla is the first and only amyloid
plaque-targeting therapy that used a limited-duration treatment
regimen based on amyloid plaque removal; nearly half of study
participants completed their course of treatment with Kisunla in 12
months
Once-monthly infusions of 30 minutes reduced
amyloid plaques on average by 84% compared to the start of the
study
INDIANAPOLIS, July 2, 2024
/PRNewswire/ -- The U.S. Food and Drug Administration (FDA)
approved Kisunla™ (donanemab-azbt, 350 mg/20 mL once-monthly
injection for IV infusion), Eli Lilly and Company's (NYSE: LLY)
Alzheimer's treatment for adults with early symptomatic Alzheimer's
disease (AD), which includes people with mild cognitive impairment
(MCI) as well as people with the mild dementia stage of AD, with
confirmed amyloid pathology.1, 2 Once-monthly Kisunla is
the first and only amyloid plaque-targeting therapy with evidence
to support stopping therapy when amyloid plaques are
removed, which can result in lower treatment costs and fewer
infusions.3-6
"Kisunla demonstrated very meaningful results for people with
early symptomatic Alzheimer's disease, who urgently need effective
treatment options. We know these medicines have the greatest
potential benefit when people are treated earlier in their disease,
and we are working hard in partnership with others to improve
detection and diagnosis," said Anne
White, executive vice president and president of Lilly
Neuroscience, Eli Lilly and Company. "Our deepest thanks to the
patients and their loved ones for participating in our clinical
programs and to Lilly scientists and collaborators persevering over
decades of research. Each year, more and more people are at risk
for this disease, and we are determined to make life better for
them."
Amyloid is a protein produced naturally in the body that can
clump together to create amyloid plaques. The excessive buildup of
amyloid plaques in the brain may lead to memory and thinking issues
associated with Alzheimer's disease.7, 8 Kisunla can
help the body remove the excessive buildup of amyloid plaques and
slow the decline that may diminish people's ability to remember new
information, important dates, and appointments; plan and organize;
make meals; use household appliances; manage finances; and be left
alone.1, 7-9
In the TRAILBLAZER-ALZ 2 Phase 3 study, people who were the
least advanced in the disease experienced the strongest results
with Kisunla. Trial participants were analyzed over 18 months in
two groupings: one group who was less advanced in their disease
(those with low to medium levels of tau protein) and the overall
population, which also included participants with high tau
levels.1, 10, 11 Treatment with Kisunla significantly
slowed clinical decline in both groups.1 Those
individuals treated with Kisunla who were less advanced in their
disease showed a significant slowing of decline of 35% compared
with placebo on the integrated Alzheimer's Disease Rating Scale
(iADRS), which measures memory, thinking, and daily functioning. In
the overall population, the response to treatment was also
statistically significant using the iADRS at 22%.1,
12 Among the two groups analyzed, participants treated
with Kisunla had up to a 39% lower risk of progressing to the next
clinical stage of disease than those taking
placebo.13
Among the overall population of participants, Kisunla reduced
amyloid plaques on average by 61% at 6 months, 80% at 12 months,
and 84% at 18 months compared to the start of the study.1,
14 One of the treatment goals of the study was to remove
amyloid plaques to minimal levels consistent with a visually
negative scan using amyloid positron emission tomography (PET). If
participants were confirmed to have reached these levels, they were
able to complete treatment with Kisunla and switch to placebo for
the remainder of the study.
Kisunla can cause amyloid-related imaging abnormalities (ARIA),
which is a potential side effect with amyloid plaque-targeting
therapies that does not usually cause symptoms. It can be detected
via magnetic resonance imaging (MRI) scans and, when it does occur,
may present as temporary swelling in an area or areas of the brain,
which usually resolves over time, or as small spots of bleeding in
or on the surface of the brain. Infrequently, larger areas of
bleeding in the brain can occur.1, 2
ARIA can be serious, and life-threatening events can occur. Kisunla
can also cause certain types of allergic reactions, some of which
may be serious and life-threatening, that typically occur during
infusion or within 30 minutes post-infusion. Headache is another
commonly reported side effect. See the Indication and Safety
Summary with Warnings below for additional
information.
"This approval marks another step forward in evolving the
standard of care for people living with Alzheimer's disease that
will ultimately include an arsenal of novel treatments, providing
much needed hope to the Alzheimer's community. As a physician, I am
encouraged by the potential to stop treatment, which could reduce
out-of-pocket costs and infusion burden for eligible patients,"
said Howard Fillit, M.D., Co-Founder
and Chief Science Officer at the Alzheimer's Drug Discovery
Foundation (ADDF). "Diagnosing and treating Alzheimer's sooner than
we do today has the potential to meaningfully slow disease
progression, giving patients invaluable time to maintain their
independence for longer."
Cost and Coverage
In the TRAILBLAZER-ALZ 2 trial,
people were able to complete treatment and switch to placebo at 6,
12, or 18 months after they achieved one of the study's treatment
goals, minimal levels of amyloid plaque consistent with a visually
negative amyloid PET scan. In the overall population of people
receiving Kisunla, 17% completed treatment at 6 months, 47% at 12
months, and 69% at 18 months based on an assessment of amyloid
levels via an amyloid PET scan.1
Kisunla
Limited-Duration Treatment Examples
|
Length of Treatment
|
6 months
|
12 months
|
18 months
|
30-Minute Infusions
|
6
|
13
|
19
|
Course of Therapy Cost
|
$12,522
|
$32,000
|
$48,696
|
Note: The
price of each vial of Kisunla is $695.65.
|
The total cost of Kisunla will vary by patient based on when
they complete treatment. The FDA's dosing instructions state that
prescribers can consider stopping the dosing of Kisunla based on
removal of amyloid plaques to minimal levels as observed on amyloid
PET imaging. The potential to complete treatment after a
limited-duration course of therapy, along with 30-minute infusions
once per month, could result in lower patient out-of-pocket
treatment costs and fewer infusions compared to other
amyloid-targeting therapies.6
Patients' out-of-pocket cost for treatment with Kisunla will
depend on their length of treatment and their insurance. Coverage
and reimbursement for Kisunla are now available for eligible
patients on Medicare under a National Coverage Determination
with Coverage with Evidence Development. Also, as of October 2023, broad coverage and reimbursement
for amyloid PET scans are available for eligible patients on
Medicare. More than 98% of eligible Medicare patients have coverage
that eliminates, limits, or caps their annual out-of-pocket
exposure.15
Lilly Support Services for Kisunla is a free support program
committed to helping patients navigate treatment with Kisunla. The
program includes offerings such as coverage determination
assistance, care coordination, nurse navigator support, and
customized support and resources. For more information about Lilly
Support Services and Kisunla, visit www.Kisunla.Lilly.com or call
1-800-LillyRx (1-800-545-5979).
Lilly Donating to Lilly Cares Foundation
Lilly intends to donate Kisunla to the Lilly Cares Foundation, a
separate nonprofit organization that makes medicines available at
no cost to qualified Americans, including some Medicare
beneficiaries, who meet financial eligibility and other criteria.
This is consistent with Lilly's long history of supporting access
to our products to patients with financial need through medication
donations to charitable organizations. Learn more about the Lilly
Cares Foundation, including eligibility criteria, at
www.lillycares.com.
A media kit is available on Lilly.com with additional
resources.
About Kisunla™ (donanemab-azbt)
Kisunla™ (donanemab-azbt) (pronounced kih-SUHN-lah) is an
amyloid-targeting treatment for people with mild cognitive
impairment (MCI) as well as people with mild dementia stage of
early symptomatic Alzheimer's disease, with confirmed amyloid
pathology. Kisunla can cause serious side effects, including
amyloid-related imaging abnormalities, or ARIA, and
infusion-related reactions. Kisunla is a prescription medicine
administered intravenously every four weeks, 700 mg for the first
three doses and 1400 mg thereafter.
About TRAILBLAZER-ALZ 2 Study and the TRAILBLAZER-ALZ
program
TRAILBLAZER-ALZ 2 (NCT04437511) is a Phase 3,
double-blind, placebo-controlled study to evaluate the safety and
efficacy of donanemab in participants with early symptomatic
Alzheimer's disease (MCI or mild dementia due to Alzheimer's
disease) with the presence of confirmed Alzheimer's disease
neuropathology. The trial enrolled 1,736 participants, across 8
countries, selected based on cognitive assessments in conjunction
with evidence of Alzheimer's disease pathology. 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,
including TRAILBLAZER-ALZ 3, which is focused on preventing
symptomatic Alzheimer's disease in participants with preclinical
AD; TRAILBLAZER-ALZ 5, a registration trial for early symptomatic
AD currently enrolling in China
and Korea; and TRAILBLAZER-ALZ 6, which is focused on expanding our
understanding of ARIA through novel MRI sequences, blood-based
biomarkers, and different dosing regimens of donanemab.
INDICATION AND SAFETY SUMMARY WITH WARNINGS
Kisunla™ (kih-SUHN-lah) is used to treat adults with
early symptomatic Alzheimer's disease (AD), which includes mild
cognitive impairment (MCI) or mild dementia stage of disease.
Warnings - Kisunla can cause
Amyloid-Related Imaging Abnormalities or "ARIA." This is a
common side effect that does not usually cause any symptoms, but
serious symptoms can occur. ARIA can be fatal. ARIA is most
commonly seen as temporary swelling in an area or areas of the
brain that usually goes away over time. Some people may also have
spots of bleeding on the surface of or in the brain and
infrequently, larger areas of bleeding in the brain can occur.
Although most people do not have symptoms, some people have
headache, dizziness, nausea, difficulty walking, confusion, vision
changes, and seizures.
Some people have a genetic risk factor (homozygous
apolipoprotein E ε4 gene carriers) that may cause an increased risk
for ARIA. Talk to your healthcare provider about testing to see if
you have this risk factor.
You may be at higher risk of developing bleeding in the brain if
you take medicines to reduce blood clots from forming
(antithrombotic medicines) while receiving Kisunla. Talk to your
healthcare provider to see if you are on any medicines that
increase this risk.
Your healthcare provider will do magnetic resonance imaging
(MRI) brain scans before and during your treatment with Kisunla to
check you for ARIA. You should carry information that you are
receiving Kisunla, which can cause ARIA, and that ARIA symptoms can
look like stroke symptoms. Call your healthcare provider or go
to the nearest hospital emergency room right away if you have any
of the symptoms listed above.
There are registries that collect information on treatments for
Alzheimer's disease. Your healthcare provider can help you become
enrolled in these registries.
Warnings - Kisunla can cause serious allergic and
infusion-related reactions. Do not receive Kisunla if you have
serious allergic reactions to donanemab-azbt or any of the
ingredients in Kisunla. Symptoms may include swelling of the
face, lips, mouth, or eyelids, problems breathing, hives, chills,
irritation of skin, nausea, vomiting, sweating, headache, or chest
pain. You will be monitored for at least 30 minutes after you
receive Kisunla for any reaction. Tell your healthcare provider
right away if you have these symptoms or any reaction during or
after a Kisunla infusion.
Other common side effects
Tell your healthcare provider right away if you have any side
effects. These are not all of the possible side effects of
Kisunla. You can report side effects at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Before you receive Kisunla, tell your healthcare
provider:
- About all medicines you take, including prescription and
over-the-counter medicines, as well as vitamins and herbal
supplements. Especially tell your healthcare provider if you have
medicines to reduce blood clots from forming (antithrombotic
medicines, including aspirin).
- About all of your medical conditions including if you are
pregnant, breastfeeding, or plan to become pregnant or breastfeed.
Kisunla has not been studied in people who were pregnant or
breastfeeding. It is not known if Kisunla could harm your unborn or
breastfeeding baby.
How to receive Kisunla
Kisunla is a prescription
medicine given through an intravenous (IV) infusion using a needle
inserted into a vein in your arm. Kisunla is given once every 4
weeks. Each infusion will last about 30 minutes.
Learn more
For more information about Kisunla, call
1-800-LillyRx (1-800-545-5979) or go
to kisunla.lilly.com.
This summary provides basic information about Kisunla. It does
not include all information known about this medicine. Read the
information given to you about Kisunla. This information does not
take the place of talking with your healthcare provider. Be sure to
talk to your healthcare provider about Kisunla. Your healthcare
provider is the best person to help you decide if Kisunla is right
for you.
Please see full Prescribing
Information including boxed warning for ARIA
and Medication Guide for Kisunla.
DN CON BS APP
Kisunla™ and Lilly Support Services™ are trademarks
owned or licensed by Eli Lilly and Company, its subsidiaries, or
affiliates.
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
PP-DN-US-0193 07/2024
© Lilly USA, LLC 2024. ALL
RIGHTS RESERVED.
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 Kisunla (donanemab-azbt) as a treatment for people with
early symptomatic Alzheimer's disease, the supply and
commercialization of Kisunla, and future readouts, presentations,
and other milestones relating to Kisunla and reflects Lilly's
current beliefs and expectations. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of drug research, development, and
commercialization. Among other things, there is no guarantee that
planned or ongoing studies will be completed as planned, that
future study results will be consistent with study findings to
date, that Kisunla will receive additional regulatory approvals or
that Kisunla will be commercially successful. 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.
References
- Kisunla (donanemab-azbt). Prescribing Information. Lilly
USA, LLC.
- Kisunla (donanemab-azbt). Medication Guide. Lilly
USA, LLC.
- Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early
Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized
Clinical Trial. JAMA. 2023;330(6):512-527.
doi:10.1001/jama.2023.13239.
- Ross EL, Weinberg MS, Arnold SE. Cost-effectiveness of
Aducanumab and Donanemab for Early Alzheimer Disease in the US.
JAMA Neurol. 2022;79(5):478-487.
doi:10.1001/jamaneurol.2022.0315.
- Boustani M, Doty EG, Garrison LP Jr, et al. Assessing the
Cost-effectiveness of a Hypothetical Disease-modifying Therapy With
Limited Duration for the Treatment of Early Symptomatic Alzheimer
Disease. Clin Ther.
2022;44(11):1449-1462.
doi:10.1016/j.clinthera.2022.09.008.
- Mattke S, Ozawa T and Hanson M. Implications of Treatment
Duration and Intensity on the Value of Alzheimer's Treatments.
Clinical Trials on Alzheimer's Disease. Oct.
24-27, 2023.
- Porsteinsson AP, Isaacson RS, Knox S, et al. Diagnosis of
early Alzheimer's disease: clinical practice in 2021. J Prev
Alzheimers Dis. 2021;8:371-386.
- Alzheimer's Association. 2023 Alzheimer's disease facts and
figures. Alzheimers Dement. 2023;19(4):1598-1695
- Wessels AM, Dennehy EB, Dowsett SA, et al. Meaningful
clinical changes in Alzheimer disease measured with the iADRS and
illustrated using the donanemab TRAILBLAZER-ALZ study findings.
Neurol Clin Pract. 2023;13(2):e200127.
doi:10.1212/CPJ.0000000000200127
- Bucci M, Chiotis K, Nordberg A; Alzheimer's Disease
Neuroimaging Initiative. Alzheimer's disease profiled by fluid and
imaging markers: tau PET best predicts cognitive decline. Mol
Psychiatry. 2021 Oct;26(10):5888-5898. doi:
10.1038/s41380-021-01263-2.
- Boccalini C, Ribaldi F, Hristovska I, Arnone A, Peretti DE,
Mu L, Scheffler M, Perani D, Frisoni GB, Garibotto V. The impact of
tau deposition and hypometabolism on cognitive impairment and
longitudinal cognitive decline. Alzheimers Dement. 2023
Aug 9. doi:
10.1002/alz.13355.
- Data on File. Lilly USA,
LLC. DOF-DN-US-0053.
- Data on File. Lilly USA,
LLC. DOF-DN-US-0055.
- Data on File. Lilly USA,
LLC. DOF-DN-US-0029.
- Naber J. Alzheimer's disease:
An analysis of the diagnosed population and out-of-pocket cost
exposure. Milliman Brief. February
2024.
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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