On June 7th of 2021, the FDA made a shocking announcement that could change the treatment of current patients, especially those in the earlier stages, suffering from Alzheimer's. The new drug developed by Biogen, is known as Aduhelm (aducanumab) and it’s the first treatment of its kind regarding Alzheimer's. This is due to its intended role of targeting the physiological effects of the disease and the FDA’s accelerated approval has allowed it to become a promising cure, not only for Alzheimer's, but also for other neurodegenerative diseases.
Aduhelm is intended to reduce the changes in the brain that occur from Alzheimer’s. Currently, scientists assume that Alzheimer is caused by changes in the brain such as build up of the protein amyloid, loss of neurons and their connections, and more; however, the direct cause of Alzheimer’s is yet to be found. The new drug Aduhelm claims to reduce the amyloid plaque buildup in the brain, and this is the first new treatment for Alzheimer’s approved since 2003. Patients of other neurodegenerative diseases also believe this could be the beginning of re-sparked interest in cures for neurodegenerative diseases overall as the lack of profit discouraged most pharmaceutical companies.
This new treatment plan, just like many other drugs in the market, also causes negative side effects. It may cause brain swelling and bleeding which requires close monitoring. Aduhelm also warns its patients of ARIA, an amyloid-related imaging abnormality that resolves naturally, but may cause headaches, dizziness, and more symptoms. Other side effects include hypersensitivity reactions such as angioedema, swelling beneath the skin, and urticaria, commonly known as skin rashes.
In order to allow patients access to this drug, however, the FDA used its accelerated approval pathway system which has created even more doubts regarding its effectiveness. Usually when the drug may take too long to prove beneficial and in order to possibly improve suffering patients’ conditions, the accelerated approval pathway allows the FDA to approve the use of a drug to the public without being 100% sure of its benefits. The evidence submitted by Biogen is only required to show that it will likely be beneficial and also allows the FDA to later withdraw its former approval of the drug. This has allowed the drug to be approved without showing clear cognitive benefits but, rather, based on its possible effects on amyloid plaques. The same approach has been taken before in approving the uses of drugs for cancer. The FDA allowed patients in the later stages of cancer access to the highly, likely to be beneficial, drugs that could not have been approved regularly. Unlike former instances of accelerated approval pathway drugs, however, the FDA raised concerns when it made the drug available to all patients suffering from Alzheimer's whether in the earlier stages or in the later stages.
Other concerns regarding Aduhelm’s performance were made by scientists and experts in the field as the drug potentially created no substantial changes regarding treatment of Alzheimer’s in the brain. The first trial showed minimal reduction of amyloid plaques for those in late stage of Alzheimer’s and none in an identically designed second trial. Even supporters of the approval of the drug, such as the Alzheimer’s Association, claimed that approval for use on patients should have been limited. Further concerns arose due to the possible decline in quality of future drugs approved by the FDA.
After facing such criticisms, the FDA reversed their previous statement on Aduhelm on July 8th, in order to encompass only those at a mild stage of Alzheimer's. This would allow Medicare and other insurance companies to also reduce their money spent as it limits patients of moderate and late stages of Alzheimer’s to pay out of their own pockets to try Aduhelm.
Although the new treatment for Alzheimer’s ended up not working as many had hoped, despite its promising beginnings, through this experience, they have shown the public that they are willing to take a more active approach in the treatment of Alzheimer’s. Therefore, many can now hope that an effective treatment may be available soon not just for Alzheimer’s but for other neurodegenerative diseases in the future.