Le Lézard
Classified in: Health
Subjects: FDA, AVO

Alzheimer's Association Statement: Alzheimer's Association Welcomes FDA Approval of Aducanumab


CHICAGO, June 7, 2021 /PRNewswire/ -- On behalf of those impacted by Alzheimer's disease, the Alzheimer's Association enthusiastically welcomes today's historic FDA approval of aducanumab (Biogen/Eisai) for treatment of Alzheimer's disease.

"This approval is a victory for people living with Alzheimer's and their families," said Harry Johns, Alzheimer's Association president and chief executive officer. "This is the first FDA-approved drug that delays decline due to Alzheimer's disease. This means individuals may have more time to actively participate in daily life, have sustained independence and hold on to memories longer. We can experience longer ? the relationships we hold most dear ? our families and friends."

Aducanumab addresses Alzheimer's in a new way compared to currently approved drugs. This therapy slows progression of the disease, rather than only addressing symptoms. It is the first approved therapy of this type; it demonstrates that removing amyloid from the brain may delay clinical decline in people living with Alzheimer's. Amyloid is the protein that clumps into sticky brain plaques that are a hallmark of Alzheimer's disease.

"This FDA drug approval ushers in a new era in Alzheimer's treatment and research," said Maria C. Carrillo, Ph.D., Alzheimer's Association chief science officer. "History has shown us that approvals of the first drug in a new category invigorates the field, increases investments in new treatments and encourages greater innovation. We are hopeful and this is the beginning ? both for this drug and for better treatments for Alzheimer's."

"Eliminating barriers to access is our highest priority," said Joanne Pike, Dr.P.H., Alzheimer's Association chief strategy officer. "The Alzheimer's Association will do everything in its power to ensure access to the drug for all who will benefit. We know that infusion therapies have been made available under Medicare and insurance for conditions like cancer and multiple sclerosis, so it is reasonable to expect this for aducanumab."

Early diagnosis has demonstrated better health outcomes for individuals and their caregivers. The approval of this new therapy makes early detection and diagnosis even more critical to ensure individuals receive the most benefit at the earliest point possible.

"This therapy will be of great interest to many, but it is not the only important element of Alzheimer's treatment and care. The Alzheimer's Association has made it a priority to partner with health care systems, physicians, and the Center for Medicare and Medicaid Services to ensure early and accurate diagnosis, and access to treatment, care management and care planning," said Pike.

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, 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.

"We are proud of what the Alzheimer's Association has done to accelerate the drug development process, so individuals will have access to more effective treatments faster," Carrillo said. "This new drug approval, and sustained progress in the research field, is due to years of investment, unrelenting dedication, and our vision of a world without Alzheimer's and all other dementia."

Driven by Alzheimer's Association advocacy, federal investment in Alzheimer's and dementia research funding is $3.1 billion annually. The federal commitment, combined with unprecedented philanthropic support, provides the foundation for an optimistic view of the future ? which is needed, because there is much work to be done.

At any given moment the Alzheimer's Association is leading the fight. Alzheimer's Association actions established foundations that have accelerated the drug development process and made advancements like this possible, including:

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.

SOURCE Alzheimer's Association


These press releases may also interest you

at 16:20
In the Phase 3 VALOR study, the primary endpoint as measured by the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) did not reach statistical significance; however, signs of reduced disease progression across multiple...

at 16:20
Ionis Pharmaceuticals, Inc. partner Biogen today announced topline results from its placebo-controlled pivotal Phase 3 VALOR study of tofersen (BIIB067), an investigational antisense medicine being evaluated for people with superoxide dismutase 1...

16 oct 2021
Core One Labs Inc. , , (the "Company") a research and technology company focused in life sciences and on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy, congratulates Seattle's city...

16 oct 2021
Neurocrine Biosciences, Inc.  today announced that it will present key information from its movement disorder treatments for Parkinson's disease and tardive dyskinesia (TD) at the American Neurological Association (ANA) 2021 Virtual Annual Meeting...

16 oct 2021
HLNY's highest recognition, the "Award of Distinction" will be presented to Arthur Gianelli, FACHE, Chief Transformation Officer of Mount Sinai Health System and President of Mount Sinai Morningside. This award recognizes a healthcare executive who...

16 oct 2021
Regulated Information ? Inside Information ? UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that they were unable to complete review of the Biologics License...



News published on 7 june 2021 at 13:31 and distributed by: