New Recommendation from FDA Advisory Committee: Leqembi Expected to Earn Full FDA Approval to Slow Progression of Alzheimer’s Disease
Food and Drug Administration (FDA) advisory committee members recently unanimously recommended the full FDA approval of Leqembi (lecanemab) for patients with mild cognitive impairment (MCI) or dementia caused by Alzheimer’s disease.
Leqembi, which currently has accelerated approval as a treatment for Alzheimer’s Disease (AD), shows a 37% decrease when compared to placebo measured against the AD Cooperative Study-Activities of Daily Living Scale for MCI
With the recommendation from the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, the FDA will make a final decision expected by early July.
Confronting Burdens
If your mother, father or loved one could be a candidate for this drug, are you prepared to risk the side effects without knowing for sure if Alzheimer’s is truly the underlying cause of their symptoms? Is your family ready to undertake the burdens of treatment – twice monthly infusions, significant costs and possible risks of brain shrinking and bleeding?
Risk Evaluation
As Leqembi and other drugs become available and FDA approved for treating Alzheimer’s, physicians will need efficient and effective strategies to accurately identify and diagnose patients with Alzheimer’s disease to ensure appropriate prescribing, avoid side effects and optimize treatment.
According to the Alzheimer’s Association, 50-70% of symptomatic patients are misdiagnosed with Alzheimer’s disease in the generalist setting. While this number drops to 25%-30% in specialty memory clinics, diagnostic accuracy is still a great unmet medical need.
Considering the significant safety considerations of these drugs indicated to treat Alzheimer’s disease, physicians need to be able to confidently diagnose patients with Alzheimer’s so medications and their risks are not unnecessarily burdening patients who may experience cognitive impairment from other, non-Alzheimer’s disease causes. Conversely, missed Alzheimer’s diagnoses results in a missed opportunity for patients who could benefit from available drugs.
Determining the presence of amyloid is an important component of treatment with Leqembi, it remains secondary to a definitive diagnosis of MCI due to AD or AD dementia. This is for good reason. For example, in a recent study, 33% of cognitively normal 70-year-olds had amyloid deposits consistent with Alzheimer’s disease on positron emission tomography (PET) imaging.
Given that dementia and cognitive impairment can often be caused by modifiable risk factors, such as depression, hypertension or type 2 diabetes, it is important to rule out other causes of cognitive impairment before determining the presence of amyloid in the brain. This is especially critical as focusing on the presence of amyloid first could yield high rates of false-positive results.
Patients should also ensure they receive their Annual Wellness visits and cognitive assessments for physicians to check for any cognitive impairment and address modifiable risk factors.
Real-World Data Registry
Another hurdle to accessing drugs is the new registry requirement from the Centers of Medicare and Medicaid Services (CMS). CMS will cover drugs like Leqembi through the use of a registry which collects data on the patients who are prescribed the drugs once they are fully FDA-approved. Experts argue that this could serve as another hurdle for patients and families seeking treatments for Alzheimer’s disease.
Value of DISCERN™ Test
Fortunately, the DISCERN test, the first autopsy-validated, highly accurate and minimally invasive test available to support a clinician’s definitive diagnosis of Alzheimer’s disease is available. Administered in the community setting, DISCERN provides primary care physicians (PCPs), neurologists, geriatricians and memory care clinic staff with a way to identify the right patients for drugs intended to identify appropriate candidates for these new Alzheimer’s treatments.
With this innovative technology, patients and families can determine if symptoms truly are from Alzheimer’s diseaseversus other, possibly curable conditions, giving individuals an opportunity to get the right treatment plan sooner—while giving families greater peace of mind.
The implications of the test are significant, with a study of 402 primary care physicians demonstrating clinicians were five times more likely to diagnose Alzheimer’s and three times as likely to prescribe disease-modifying drugs for Alzheimer’s disease with a positive DISCERN test.
DISCERN Answers the Demands for an Early, Accurate Diagnosis
Unlike other diagnostic tests for Alzheimer’s disease, DISCERN is autopsy-validated to identify Alzheimer’s in people recently diagnosed with dementia. No other diagnostic tests have undergone this rigorous autopsy validation for early dementia and no autopsy-validated tests are available to accurately diagnose MCI due to Alzheimer’s disease.
DISCERN is designed to inform the presence of Alzheimer’s disease in people recently diagnosed with dementia, even when they have mixed dementia. The DISCERN test assesses the factors directly related to the formation of synaptic connections in the brain impacting loss of memory and cognition in people living with Alzheimer’s disease as well as regulators of amyloid plaque and tau formation, hallmarks of Alzheimer’s at autopsy. DISCERN is currently paid for by Medicare and some state Medicaid plans.
Contact SYNAPS Dx for more information on testing for Alzheimer’s disease.
* The DISCERN™ test was developed and its performance characteristics determined by NeuroDiagnostics Inc, dba Synaps Dx. It has not been cleared or approved by the U.S. Food and Drug Administration. NeuroDiagnostics, Inc. is regulated under the Clinical Laboratory Improvement Amendments (CLIA) as an accredited laboratory to perform high complexity clinical testing. The test is intended for patients with dementia. Test results should be interpreted in conjunction with other laboratory and clinical data available