In June, the Food and Drug Administration (FDA) released approval for Aduhelm, a form of treatment for Alzheimer’s. Currently, Alzheimer’s affects nearly 6.2 million Americans, so the drug was put on an accelerated approval pathway intended for drugs that aim to treat serious or life-threatening illnesses and provide a therapeutic advantage over existing treatments. Accelerated approval is based on the drug’s impact on the reasonable likelihood of providing a clinical benefit to patients.
Patrizia Cavazzoni M.D., the FDA’s Center for Drug Evaluation and Research Director, says of the new drug, “Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones…Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy 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 therapies to patients faster while spurring more research and innovation.”
Aduhelm is the first of its kind and the first new approved treatment since 2003. It is also the first therapy that targets the fundamental pathophysiology of Alzheimer’s. Efficacy in studies proved significant, which is great news for seniors at assisted living Casper WY and across the world. The results are what led to the accelerated approval. Under the approval process provisions, patients currently suffering from Alzheimer’s can have earlier access to the treatment. It also states that manufacturer Biogen must conduct a new study to verify benefits, and if it fails, the FDA may withdraw approval.
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