There’s been a lot of talk going around about Biogen’s new Alzheimer’s drug, aducanumab (or Aduhelm, for those of us who have difficulty with pronunciation). Many questions have been raised. Is it safe? Will it cure, or at least prevent, the disease? Why is it so controversial? We’ve compiled some basic facts–what you need to know about Aduhelm, including its potential disadvantages and advantages.
Aduhelm was officially given the green light by the FDA in June. It represents the first new drug for Alzheimer’s treatment since Namenda, which was approved by the FDA in 2003. Unlike Namenda, however, which helps to alleviate the symptoms of the disease, Aduhelm is designed to specifically slow the progress of the disease itself. The FDA used its Accelerated Approval Program to bring the drug to the market on an expedited timeline. This means that clinical trial results have been positive enough to predict an overall benefit to Alzheimer’s patients, but there is still more research to be done to determine a definite, positive result. Though initially approving Aduhelm for all Alzheimer’s patients, the FDA has now narrowed their recommendation to patients experiencing early stages of the disease.
Last fall, an FDA advisory committee concluded that not enough evidence existed to support the effectiveness of Aduhelm. In addition, two different committees in the House of Representatives have now opened investigations into the approval process of the drug, as well as its cost to consumers. In case you’re wondering, it will come to about $4,312 per treatment, or around $56,000 annually. Furthermore, a number of medical professionals have spoken up in disagreement with the FDA’s approval decision, saying that not enough favorable evidence exists to support bringing the drug to the market. More importantly, there is concern that the FDA has disregarded some potentially severe side effects from the drug. Dr. Aaron Kesselheim, who served on the advisory committee mentioned above, resigned after learning of the approval, saying, “The aducanumab decision by FDA administrators was probably the worst drug approval decision in recent U.S. history.”
The drug has been widely tested on 3,482 Alzeimer’s patients across three different placebo-controlled studies. Those patients receiving Aduhelm experienced significant reduction of amyloid plaques in the brain, which are believed to be a primary contributor to the development of Alzheimer’s Disease. And further trials are forthcoming, known as phase 4 confirmatory trials, which are meant to officially verify the drug’s benefits. If Aduhelm is shown to not be as effective as anticipated in pre-approval trials, the FDA is able to remove it from the market. It is also worth noting that Alzheimer’s Disease is the sixth leading cause of death in the United States, and Aduhelm is the first drug to produce widely positive results in slowing down the progress of the disease. For some, there is very little time to wait. Finally, Dr. Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, has said, “In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”
There are numerous factors to consider regarding not only Aduhelm, but the FDA’s approval of the drug. There are seemingly endless opinions and ongoing analyses, and many unanswered questions. If you are considering taking Aduhelm, consult with your primary care physician. Talk with your family and loved ones. Ultimately, the decision belongs to you.