Great Britain
is the third major market where donanemab has received
approval
Donanemab was first approved in the United States in July 2024 and then approved in Japan in September
2024
INDIANAPOLIS, Oct. 23,
2024 /PRNewswire/ -- Eli Lilly and Company (NYSE:
LLY) announced today that the Medicines and Healthcare products
Regulatory Agency (MHRA) has granted marketing authorization for
donanemab, an injection for intravenous infusion every four weeks
to treat mild cognitive impairment and mild dementia due to
Alzheimer's disease in eligible adults in Great Britain. Eligible patients are limited
to apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers,
which is a requirement for the class of currently approved
amyloid-targeting therapies in Great
Britain. Donanemab is the only amyloid plaque-targeting
therapy with evidence to support stopping therapy when amyloid
plaques are removed. Great Britain
is the third major market to approve donanemab, marketed as
Kisunla.
"People around the world want and deserve access to treatment
options for this disease. This approval in Great Britain is another significant step to
ensure patients with Alzheimer's disease can receive treatment with
this new class of amyloid targeting therapies, which could give
them more time in the early symptomatic stage of the disease to do
what matters most to them," said Ilya
Yuffa, executive vice president and president of Lilly
International, Eli Lilly and Company. "Donanemab demonstrated
meaningful results for people with early symptomatic Alzheimer's
disease by significantly slowing cognitive and functional decline
in our TRAILBLAZER-ALZ 2 study."
Currently, there are 982,000 people estimated to be living with
dementia in the United Kingdom
(UK)1, with 50-75% of cases attributable to Alzheimer's
disease.2 It is the leading cause of death3
in the UK and an economic cost to society. The total cost of
dementia on patients, families and the public sector is estimated
to be £42 billion in 2024. Unpaid care is the largest component,
with costs per person increasing threefold from mild to severe
dementia.4
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. Donanemab can help the
body remove the excessive buildup of amyloid plaques and slow the
cognitive and functional decline that may diminish people's ability
to remember information, make meals, manage finances, and maintain
independence.
"I believe we can improve the standard of care for people living
with Alzheimer's disease. Despite years of medical research, until
recently, there has been little progress in treatment options for
this disease. The authorisation of donanemab for eligible adults is
welcome news. Great Britain now
needs to rapidly increase National Health Service (NHS) capacity
and expertise in diagnostics and treatment facilities to enhance
the management of Alzheimer's disease for the benefit of people
today and tomorrow," said Professor Cath
Mummery, Consultant Neurologist at University College London
Hospitals NHS Foundation Trust and Chair of the NIHR Dementia
Translational Research Collaboration.
About Donanemab
Donanemab is an amyloid-targeting treatment for people with mild
cognitive impairment and mild dementia due to Alzheimer's disease
in adult patients who are apolipoprotein E ε4 (ApoE ε4)
heterozygotes or non-carriers. Donanemab can cause serious side
effects, including amyloid-related imaging abnormalities (ARIA),
and infusion-related reactions. Donanemab is a fixed dose
prescription medicine administered intravenously every four
weeks.
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 (mild cognitive impairment 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 reducing risk of
progression to 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.
U.S. INDICATION AND SAFETY SUMMARY WITH WARNINGS
Kisunla™ (donanemab-azbt), pronounced
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
headaches, 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.
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 tens of millions of 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 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
1. Carnall Farrar (2024). The Economic Impact of
Dementia. Available from:
https://www.carnallfarrar.com/wp-content/uploads/2024/05/Alz-report.pdf
[Accessed September 2024]
2. National Institute for Health and Care Excellence (2023).
Potential issues and challenges in evaluation of disease-modifying
dementia treatments. Available from:
https://www.nice.org.uk/Media/Default/About/what-we-do/HTA%20Lab/HTA-lab-dmdt.pdf
[Accessed September 2024]
3. Office for National Statistics (2020). Leading causes of
death, UK: 2001 to 2018. Available from:
https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/causesofdeath/articles/leadingcausesofdeathuk/2001to2018#uk-leading-causes-of-death-for-all-ages
[Accessed September 2024]
4. Carnall Farrar (2024). The Economic Impact of
Dementia. Available from:
https://www.carnallfarrar.com/wp-content/uploads/2024/05/Alz-report.pdf
[Accessed September 2024]
5. Kisunla (donanemab-azbt). Prescribing Information. Lilly
USA, LLC.
6. 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.
7. 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.
8. Data on File. Lilly USA,
LLC. DOF-DN-US-0053.
9. Data on File. Lilly USA,
LLC. DOF-DN-US-0055.
10. Data on File. Lilly USA,
LLC. DOF-DN-US-0029.
11. 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.
Refer
to:
|
Aaron Fobes;
aaron.fobes@lilly.com; 463-230-2378 (Media)
|
|
Joe Fletcher;
jfletcher@lilly.com; 317-296-2884 (Investors)
|
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