Controversial New Alzheimer’s Drug, Aducanumab, Now FDA Approved

The latest drug for treating Alzheimer’s, Aducanumab (also known by the brand name Aduhelm), has recently been granted accelerated approval from the FDA. Alzheimer’s is a debilitating disease that affects 6.2 million Americans and currently has only had therapies that address the symptoms of Alzheimer’s. 

Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research states that this drug “is the first therapy to target and affect the underlying disease process of Alzheimer’s,” in regards to the type of treatment Aducanumab is bringing forth. Aducanumab is also the first drug introduced to treat Alzheimer’s Disease since 2003.

Other drugs on the market for Alzheimer’s disease are known to treat and relive symptoms of this condition, however, the trials for Aducanumab have shown that it slows the progression of amyloid beta plaque which is associated with Alzheimer’s in patients during the early stages of the disease. Research found that those receiving the drug during the double-blind, randomized, placebo-controlled trials had a reduction in the plaques while those who did not receive the drug had no plaque reduction. 

The controversy behind this drugs approval is within the findings of this study. While it showed a slowing of progression, there was no clear depiction of a lessening of symptoms for Alzheimer’s disease if they took the drug and if there were, the benefit was small. Because of this, the FDA has asked the manufacturer, Biogen, to begin another trial to verify that this therapy is actually effective. Failure to provide proof will result in a revocation of FDA approval. 

Side effects of this drug include cerebral edema (swelling of the brain), bleeding from the brain, amyloid-related imaging abnormalities, angioedema (swelling beneath the skin) and urticaria (a hive-like reaction). Administration of the drug is an intravenous infusion for an hour every 4 weeks. 

Experts are saying that this drug is only a facet of the entirety of Alzheimer’s and its treatment. Early diagnosis, access to treatment, care management, and care planning are a part of the components associated with treating this disease.