CHICAGO, July 2, 2024
/PRNewswire/ -- The Alzheimer's Association celebrates today's U.S.
Food and Drug Administration (FDA) action to approve Kisunla™
(donanemab, Eli Lilly) for the treatment of people living with
early symptomatic Alzheimer's disease, which includes mild
cognitive impairment and the mild dementia stage of Alzheimer's
disease, with confirmed amyloid plaques.
"This is real progress. Today's approval allows people more
options and greater opportunity to have more time," said
Joanne Pike, DrPH, Alzheimer's
Association president and CEO. "Having multiple treatment options
is the kind of advancement we've all been waiting for — all of us
who have been touched, even blindsided, by this difficult and
devastating disease."
Because multiple FDA-approved Alzheimer's treatments are now
available, early detection and diagnosis are even more critical to
ensure individuals receive the most benefit. Access to these
treatments should not be delayed at any stage or by any entity —
not the Centers for Medicare & Medicaid Services (CMS) coverage
with evidence development policy, private insurers, health systems
or doctors.
"Too many roadblocks have prevented individuals from getting
equitable access to these beneficial treatments for far too long,"
said Pike. "It is equally important that clinicians and health care
systems are informed and prepared to help the individuals who could
benefit. The Alzheimer's Association is working with health systems
and providers to ensure they have the tools and resources to meet
the needs of their patients."
The Association strongly encourages prescribers to participate
in the Alzheimer's Network for Treatment and Diagnostics (ALZ-NET),
which is gathering real world data on how people from all
backgrounds and communities respond to novel FDA-approved
Alzheimer's therapies. ALZ-NET provides ongoing education and
resources for clinicians, patients, and families, helping them stay
informed about the latest developments in Alzheimer's research and
care.
"These recent approvals generate hope for continued advances.
For researchers, our next horizon is to develop new treatments that
address different components of the disease, and that work together
to have an even bigger effect on slowing or stopping disease
progression for all communities," said Maria C. Carrillo, Ph.D., chief science officer
and medical affairs lead, Alzheimer's Association.
This is the third approval of an Alzheimer's treatment that
changes the underlying course of the disease. Results from studies
of a wide variety of Alzheimer's and dementia therapies will be
reported at the Alzheimer's Association International
Conference® (AAIC®), July 28 to August 1 in Philadelphia.
"Today's decision by the FDA is good news for those of us living
with early Alzheimer's," said Barbara
Eades, of Chattanooga,
Tennessee, who was diagnosed with mild cognitive impairment
(MCI) in 2018. "I was fortunate to participate in the clinical
trial and receive this treatment. It has provided me an opportunity
to live my life fully, for more time. I'm able to keep doing what
I'm passionate about: sing, remain active in my church and spend
time with my friends and family."
The Alzheimer's Association is disappointed that so little
progress is being made to improve representation of all affected
populations in Alzheimer's clinical trials. For example,
Alzheimer's and other dementia disproportionately affect
Black/African Americans and Hispanic/Latino Americans yet, too
often, these groups are severely underrepresented in treatment
studies. It is critical that clinical trial study populations
reflect the communities these treatments intend to serve.
If you or a loved one is experiencing memory changes, the
Alzheimer's Association strongly encourages speaking with a health
care provider for a thorough evaluation and diagnosis and to
discuss treatment options. For more information on diagnosis or to
find a local health care provider, visit the Alzheimer's
Association at alz.org, or the Helpline 24/7 at 800.272.3900.
Alzheimer's Association
The Alzheimer's Association
leads the way to end Alzheimer's and all other dementia — by
accelerating global research, driving risk reduction and early
detection, and maximizing quality care and support. Our vision is a
world without Alzheimer's and all other dementia. Visit alz.org or
call the 24/7 Helpline at 800.272.3900.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/alzheimers-association-welcomes-us-fda-approval-of-kisunla-donanemab-302188365.html
SOURCE Alzheimer's Association