Aducanumab, sold under the brand name Aduhelm, is a medication designed to treat Alzheimer’s disease (AD). It is an amyloid beta-directed monoclonal antibody that targets aggregated forms (plaque) of amyloid beta (Aβ) found in the brains of people with Alzheimer’s disease to reduce its buildup. It was developed by Biogen and Eisai.
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Aducanumab is indicated for the treatment of Alzheimer’s disease. In July 2021, the U.S. Food and Drug Administration (FDA) limited the indication to people with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Aducanumab is a monoclonal IG1 antibody that binds to the amyloid beta protein at amino acids 3–7, which is posited to result in slowing the progression of Alzheimer’s disease.
Aducanumab was approved for medical use in the United States by the Food and Drug Administration (FDA) in June 2021, in a controversial decision that led to the resignation of three advisers to the FDA in the absence of evidence that the drug is effective. The FDA stated that it represents a first-of-its-kind treatment approved for Alzheimer’s disease and that it is the first new treatment approved for Alzheimer’s since 2003. Aducanumab’s approval is controversial due to ambiguous clinical trial results surrounding its efficacy.