First New Alzheimer’s Treatment Approved by FDA in Almost Two Decades

Big news for the Alzheimer’s community: The FDA just granted accelerated approval for Aduhelm (aducanumab). Aduhelm is the first drug to be approved for Alzheimer’s disease (AD) since 2003.

 

In the FDA’s release, Patrizia Cavazzonni, M.D., the director of the FDA’s Center for Drug Evaluation and Research stated, “This treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s.” Previously, available therapies only treated symptoms of the disease. “As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation,” Cavazzoni added.

To evaluate the efficacy of Aduhelm, researchers conducted three separate studies that included a total of 3,482 patients. The studies consisted of double-blind, randomized, placebo-controlled dose-ranging studies in patients with Alzheimer’s disease. Patients who received the treatment had significant dose-and-time-dependent decreases in amyloid beta plaque. Patients in the control group did not show any decreases. Amyloid beta plaque in areas of the brain affected by AD pathology was quantified using positron emission tomography (PET). The promising results in patients who received treatment supported the accelerated approval of Aduhelm.

Following the FDA’s announcement on June 7, Dr. Maria Carrillo, M.D., Chief Science Officer of the Alzheimer’s Association sent a message to the Alzheimer’s Association science community thanking them for the collaborative effort and continued work leading up to this historic moment.

 

Below is an excerpt from Dr. Carrillo’s letter:

It is important to acknowledge that this FDA-approved treatment slows progression (in a limited population) of MCI due to AD and early Alzheimer’s dementia. It does not stop decline or improve cognition. But, it represents an important step and progress in Alzheimer’s science. We recognize that — as with all drug therapies — there can be heterogeneity in treatment effects. More research will be needed to better understand the benefits, side effects and best application. 

The Alzheimer’s Association will do everything in its power to ensure access to the drug and requisite tests for all who will benefit. One of our highest priorities will be eliminating barriers to access. 

We know this is just the beginning of more meaningful treatment advances. We must advance effective treatment options for diverse populations living in all stages of Alzheimer’s and other dementia. And we must address Alzheimer’s through multiple pathways — more than just amyloid — with an eye toward effective combination therapies that work at different stages of the disease, pharmacological and nonpharmacological. 

 

A devastating illness that affects over 6 million Americans, Alzheimer’s impacts patients, loved ones, and caregivers. As Dr. Carrillo noted, Aduhelm does not stop, decline or improve cognition and that Alzheimer’s must be addressed through multiple pathways. Early detection and intervention is crucial for addressing Alzheimer’s, as well as monitoring and tracking disease progression. 

BrainCheck CORTEX™ technology platform helps clinicians detect cognitive impairment earlier to confidently diagnose and guide patients to treatments that lessen the burden of the disease. An accurate cognitive assessment and a proper diagnosis from a clinician are important precursors to a prescription for Aduhelm. As such, BrainCheck can be a valuable tool for clinician use to track cognitive impairment. It enables them to implement personalized recommendations through a cognitive care plan to preserve brain health and functional independence. 

At BrainCheck, we are celebrating this huge step forward for the Alzheimer’s community. Dr. Reza Ghomi, BrainCheck’s Chief Medical Officer adds, “We have been waiting a long time for a new treatment for Alzheimer’s Disease and with this treatment it’s more important than ever to accurately detect and diagnose people suffering from memory loss. These treatments will only be available to folks with a biomarker confirmed diagnosis of Alzheimer’s Disease, the first step of which is accurate characterization of their cognitive changes. This is a major step forward in bringing much needed attention to what is going on in the brains of those we care for and helping them get the best treatment possible.”

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