The U.S. Food and Drug Administration (FDA) will hold an early hearing Friday local time on a new treatment for Alzheimer’s disease, aducanumab, the first time the FDA has considered giving the green light to a new drug for the disease since 2004. This will be a hearing of the FDA’s Advisory Committee on Peripheral and Central Nervous System Drugs to decide whether approval for the experimental Biogen drug should be recommended.
Even if the committee’s decision is yes, it’s not clear whether the FDA will ultimately approve aducanumab’s public use. The FDA’s final decision on the matter may also take some time, possibly until 2021.
The results of the Aducanumab trial were mixed. The drug focuses on β-amyloid protein, which Biogen says is associated with the onset and development of Alzheimer’s disease. While the administration of this drug may not cure it, aducanumab may “delay clinical decline in patients,” pharmaceutical companies recommend.
Nearly 6 million people in the United States currently suffer from Alzheimer’s disease, which usually manifests it as a symptom of memory loss, reducing the ability to perform daily tasks and changes in activities and behaviors. As Alzheimer’s disease continues to develop, patients rely entirely on caregivers. In the end, it’s deadly.
Much research remains to be done on what causes Alzheimer’s disease and can accelerate or slow its development. Biogen’s strategy is to β-amyloid protein, a prelude to so-called nerve fiber entanglement. These later bind to synapses in the brain, destroy them and destroy them completely.
Although there are existing therapies to treat Alzheimer’s disease, aducanumab intends to be given in the early stages of the disease, which can slow the progression of nerve fiber tangles. However, the researchers have not yet found conclusive evidence of its efficacy. For example, a Phase 3 clinical trial ended in early 2019, and Biogen acknowledged that the drug is unlikely to meet its targets. However, a subsequent experiment proved to be more successful. Biogen said Aducanumab helped significantly reduce clinical decline in Alzheimer’s patients, with “stable and consistent results.”
The company then applied to the FDA for approval, but before that, Friday’s committee meeting had to give its opinion. The FDA itself is under no obligation to accept this judgment, and in fact, there are other concerns, in addition to some early indicators of clinical efficacy. Sceptics point out that limited test pools are a problem, as well as the overall cost of the proposed treatment. Biogen has not exactly indicated the exact cost of aducanumab.