On June 7, 2021, the FDA approved Biogen drug aducanumab, the first-ever disease-modifying therapy for early stage Alzheimer’s disease. Through the years, we have never let go of hope, but this feels like a true turning point. As pointed out in the UsAgainstAlzheimer’s (UsA2) press release below, with the approval of this first drug, the second, third, fourth, and beyond, should follow at a more rapid pace.
UsAgainstAlzheimer’s AlzTalks – June 9
To hear the latest, be sure to register for UsA2’s June 9th (4pm ET) AlzTalks. Click HERE to register.
Meryl Comer will moderate a discussion that will include one of Biogen’s top leaders as well as George Vradenburg, Chairman & Co-Founder of UsAgainstAlzheimer’s, Russ Paulsen, Chief Operating Officer of UsA2, and advocates Jim and Geri Taylor. Geri lives with Alzheimer’s disease and participated in the Clinical Trial for this therapy.
UsAgainstAlzheimer’s Press Release
Washington, D.C. (June 7, 2021) – UsAgainstAlzheimer’s issued the following statement from George Vradenburg, chairman and co-founder, on the Food and Drug Administration’s decision to approve Biogen’s aducanumab, the first disease-modifying therapy for early-stage Alzheimer’s.
“This first disease-slowing drug is a dramatic turning point in the fight against Alzheimer’s. Hope will replace despair for many families in the early stages of the disease.
“By delaying the progression for people in the early stages of the disease, this drug therapy promises to give people more time to live independently and perform daily activities longer.
“We believe that FDA’s approval of aducanumab will have a positive ripple effect on pharmaceutical innovation far beyond this one drug. To get to the best-in-class drug – and ultimately a cure – there must be a first-in-class drug such as aducanumab. This approval will spark additional investment by other companies in disease-modifying treatments and therapies. With approval of this first drug, drugs 2, 3, 4 will follow, and at a faster pace.
“We are very concerned about the ability of patients to gain access to aducanumab, particularly those on Medicare fee-for-service without supplemental insurance. And, shockingly, Medicare does not reimburse patients for the expensive PET scans important to determine whether someone is appropriate for this drug. We intend to work with Biogen and Medicare to make access to this drug affordable for every American who needs it.
“After so many disappointments in potential treatments, the Alzheimer’s community now knows this deadly enemy has finally been engaged. At long last, science and time are on our side. Patients in the early stages of the disease will engage with their physicians to learn what can be done, with early detection, to slow their cognitive decline and this disease.
“Because aducanumab is for people in the early stages of the disease, it will be important for people to learn whether it is right for them. Our new BrainGuide™ platform empowers people with the knowledge and confidence to take the best next steps in managing their own or a loved one’s brain health. BrainGuide is free and easy to access at mybrainguide.org or at 855-BRAIN-411.”
Lisa Genova’s Comments on the Approval of Aducanumab
Lisa Genova is a Neuroscientist, a #1 international & NY Times Bestselling Author, and a TED speaker. Her comments below can be found on Instagram. Be sure to follow Lisa at https://www.instagram.com/authorlisagenova/.
“Today, the FDA approved Aducanumab, the very FIRST disease-modifying treatment for Alzheimer’s disease.
“Aducanumab is a monoclonal antibody that clears a protein called beta-amyloid from the brain. If you’ve watched my TED talk, you’ll remember that uncleared amyloid can stick to itself, forming amyloid plaques. If the accumulation of amyloid plaques reaches a tipping point, this will trigger a molecular cascade that results in neuron death and a kind of dementia we call Alzheimer’s.
“Think of amyloid plaques below the tipping point as a lit match. After the tipping point, the brain is set on fire.
“This drug blows out the match.
“Aducanumab is currently approved for people with early-stage Alzheimer’s (lit match, brain not yet on fire) who have had a positive PET scan confirming the presence of beta-amyloid in their brains. Dosing will be by infusion, once a month. Not ideal, but a very exciting and hopeful beginning.
“This historic approval will also likely accelerate the development, approval, and reimbursement of biomarkers and simple blood tests for Alzheimer’s. In the near future, we won’t need to rely on PET scans or lumbar punctures to identify the early signs of Alzheimer’s—tests that the vast majority of folks will never have because they’re too expensive, too invasive, and not accessible.
“Much like getting your cholesterol levels checked for heart disease, we’ll soon have a blood test that measures your brain’s relative risk of becoming ablaze with Alzheimer’s. And then, again much like we do for heart disease, we’ll come up with a plan to lower that risk—through diet, exercise, managing stress, getting enough sleep, staying socially and cognitively active, and now, possibly adding a drug that clears beta-amyloid (like statins do with cholesterol).
“Today marks an exciting, massively important step in the battle against Alzheimer’s.“
Source: Lisa Genova via Instagram
Approval of Aducanumab Highlights the Need for Health Equity
While we celebrate the FDA’s approval of the first disease-modifying therapy for early-stage Alzheimer’s, we must not lose sight of the work required to ensure aducanumab and future drugs are available to ALL who need them. Without proper focus on this critical issue, current disparities in health care are only likely to widen as new treatments emerge.
In order for aducanumab to work, early diagnosis is critical. In fact, drugs like this are most successful when started before patients begin showing signs of dementia. Key diagnostics include brain imaging (PET scan) and spinal taps, both requiring high-cost specialty care that is out of the reach of many minority patients; further, Medicare does not reimburse for PET imaging.
Black people are twice as likely and Hispanic people are 1.5 times more likely than white people to have Alzheimer’s or other dementias. The wealth gap is evident in many areas and certainly, health care is one of the most significant. We must make sure the cost of diagnostics and therapies are within reach of every single American who needs them.
To learn more about how health care inequity affects many Black and Latinx families, please read this article about Sonia Cardona and her primary caregiver, daughter Daisy Duarte. Ms. Cardona developed young-onset Alzheimer’s in her 50’s and was misdiagnosed for at least five years despite a very obvious family history.