The FDA approval of Kisunla introduces a
second anti-amyloid to the market, expanding on the arsenal of
therapies needed to successfully treat Alzheimer's.
Recent approval confirms amyloids' role in
modestly slowing cognitive decline by around 30%, highlighting the
need to develop novel therapies that can be used in combination to
achieve 100% slowing of decline.
NEW
YORK, July 2, 2024 /PRNewswire/ -- Today's
FDA approval of the monoclonal antibody donanemab
(Kisunla) for the treatment of mild cognitive impairment or
early-stage Alzheimer's disease and confirmed amyloid plaques in
the brain marks the first approval of an anti-amyloid therapy with
evidence to support stopping treatment once amyloid plaques are
removed. This breakthrough, coupled with the emergence of the
biology of aging as the leading approach for drug development,
moves the field closer to treating the disease through what is
regarded as the holy grail of care, combination therapy and
precision medicine, like within cancer care.
"This approval is emblematic of the new era of Alzheimer's
research where we now have the first class of disease-modifying
drugs that will eventually be used in combination with novel
therapies—based on the biology of aging—that target all the
underlying complexities of this disease," says Howard Fillit,
MD, Co-Founder and Chief Science Officer at the Alzheimer's Drug
Discovery Foundation (ADDF). "This milestone will not only catalyze
the next generation of therapies, but also reframe how we deliver
treatments. It's promising to see that some patients essentially
enter remission, where they achieve full amyloid clearance with no
resurgence in substantial plaque buildup for several years to
follow."
Anti-amyloid drugs have proven effective at modestly slowing
cognitive decline by about one-third—and have the potential to
become the standard of care—but there remains a pressing need to
develop multiple novel drugs that target the underlying disease
biology. The current pipeline is primed to deliver in the next few
years, with nearly 75% of drugs in development focusing on targets
beyond amyloid and tau. With two drugs on the market and a robust
drug pipeline underway, the field is well-positioned to implement a
combination therapy approach, and this begins with an early and
accurate diagnosis.
"We are no longer asking whether or not we can diagnose
Alzheimer's, but, rather, how early can we detect the disease?"
adds Dr. Fillit. "With the validation of new biomarkers, especially
blood tests, we can now diagnose the disease with ease and
intervene earlier than ever, including in the preclinical phase,
opening the door prevention. We can finally deliver the right drugs
to the right patients at the right time."
Advances in biomarkers are crucial to facilitating drug
development as shown in the Kisunla study where Eli Lilly
& Company used the Amyvid® PET scan and the C2N
blood test, PrecivityAD®, both of which received early
seed-funding from the ADDF, to aid with trial enrollment and
monitoring of the drug's target engagement. The donanemab trial
reaffirms the value of drug and biomarker development occurring
simultaneously, which leads to more efficient and rigorous clinical
trials. Now, with the advent of new biomarkers, physicians will be
able to gain insight into patients' individual risk profiles,
enabling them to diagnose the disease earlier and combine
therapeutics with lifestyle interventions to slow the progression
of the disease.
"While this is exciting news for the field, it is crucial we
continue to look to a future where we can halt the progression of
Alzheimer's or prevent it altogether by developing new therapies
and biomarkers based around the biology of aging. In the next five
years, we will see firsthand how combining lifestyle interventions
and therapeutics tailored to each patient's individual needs will
further slow cognitive decline," concludes Dr. Fillit.
About The Alzheimer's Drug Discovery Foundation
(ADDF)
Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery
Foundation is dedicated to rapidly accelerating the discovery of
drugs to prevent, treat and cure Alzheimer's disease. The ADDF is
the only public charity solely focused on funding the development
of drugs for Alzheimer's, employing a venture philanthropy model to
support research in academia and the biotech industry. The ADDF's
leadership and contributions to the field have played a pivotal
role in bringing the first Alzheimer's PET scan
(Amyvid®) and blood test (PrecivityAD®) to
market, as well as fueling the current robust and diverse drug
pipeline. Through the generosity of its donors, the ADDF has
awarded more than $290 million to
fund over 750 Alzheimer's drug discovery programs, biomarker
programs and clinical trials in 20 countries. To learn more, please
visit: http://www.alzdiscovery.org/.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/alzheimers-drug-discovery-foundation-addf-statement-on-fdas-traditional-approval-of-kisunla-donanemab-302188442.html
SOURCE Alzheimer's Drug Discovery Foundation