Silver Spring, Maryland, June 7, 2021 /PRNewswire/ – Today, the US Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s disease, a debilitating disease that affects 6.2 million Americans. Aduhelm is approved for use Accelerated Approval Path, Can be used to treat serious or life-threatening diseases, and has significant therapeutic advantages compared with existing treatment methods. Accelerated approval can be based on the effect of the drug on a surrogate endpoint that can reasonably predict the clinical benefit to the patient, and post-approval trials are required to verify that the drug provides the expected clinical benefit.
“Alzheimer’s disease is a devastating disease that can have a profound impact on the lives of people diagnosed with this disease and their loved ones,” said Patricia Cavazzoni, MD, Director of FDA Drug Evaluation and Research Center. “Currently available therapies can only treat the symptoms of the disease; this treatment is the first treatment to target and affect the underlying disease process of Alzheimer’s. As we have learned from the fight against cancer , The accelerated approval pathway can bring treatments to patients faster, while stimulating more research and innovation.”
Alzheimer’s disease is an irreversible progressive brain disease that slowly destroys memory and thinking abilities, and eventually the ability to perform simple tasks. Although the specific cause of Alzheimer’s disease is not fully understood, it is characterized by changes in the brain-including amyloid plaques and neurofibrils or tau tangles-leading to the loss of neurons and their connections. These changes will affect a person’s memory and thinking ability.
Aduhelm represents the first approved treatment for Alzheimer’s disease. This is the first new treatment approved for Alzheimer’s disease since 2003, and the first treatment for the basic pathophysiology of the disease.
Researchers evaluated the efficacy of Aduhelm in three independent studies representing 3,482 patients. These studies include double-blind, randomized, placebo-controlled dose range studies in patients with Alzheimer’s disease. The dose and time-dependent amyloid plaques of the treated patients were significantly reduced, while the amyloid plaques of the patients in the study control group did not decrease.
These results support the accelerated approval of Aduhelm, which is based on the surrogate endpoint of reducing amyloid plaques in the brain, a hallmark of Alzheimer’s disease. Beta amyloid plaques are quantified using positron emission tomography (PET) imaging to estimate the brain regions expected to be widely affected by Alzheimer’s disease pathology compared to those not expected to be affected by such pathology , The brain level of beta amyloid plaques.
Aduhelm’s prescribing information includes warnings for amyloid-related imaging abnormalities (ARIA). The most common is temporary swelling of the brain area, which usually resolves over time without causing symptoms, although some people may experience headaches, etc Symptoms, confusion, dizziness, vision changes, or nausea. Another warning from Aduhelm is the risk of allergic reactions, including angioedema and urticaria. The most common side effects of Aduhelm are ARIA, headaches, falls, diarrhea and confusion/delirium/changes in mental status/disorientation.
According to the accelerated approval clause, which provides patients with the disease with an earlier opportunity for treatment, the FDA requires the company Biogen to conduct a new randomized controlled clinical trial to verify the clinical benefits of the drug. If the trial fails to verify the clinical benefit, the FDA may initiate procedures to withdraw approval of the drug.
Aduheim was awarded Expressway Designated to speed up the development and review of drugs used to treat serious diseases, in which preliminary evidence indicates that it is possible to solve unmet medical needs.
Aduhelm is manufactured by Biogen Cambridge, Massachusetts.
The FDA is an agency under the U.S. Department of Health and Human Services that protects public health by ensuring the safety, effectiveness, and safety of human and veterinary drugs, vaccines and other human biological products, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, and products that emit electronic radiation, as well as regulating tobacco products.
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SOURCE U.S. Food and Drug Administration