A controversial novel drug for Alzheimer’s disease has reportedly received approval from the U.S. FDA on 7th June 2021. The approval of this new drug, a first in almost two decades, would trigger the pressure to extend its availability across the globe despite mixed evidence pertaining to its effectiveness.
Notably, scientists have been disputing the usefulness of this novel drug named “aducanumab”. Meanwhile, there is rising desperation among patients, doctors, and organizations that support them to find treatments that could delay mental deterioration.
In March 2020, two instances were reported when trials involving the drug were stopped as it appeared to be ineffective. Aducanumab maker Biogen stated that it was unlikely that the drug would improve patients’ thinking and memory.
However, the company later conducted a reanalysis of more patient data from one of the trials, which involved people who had taken the drugs for a longer period. The data indicated that a high dose could slow the decline of thinking and memory skills along with the ability to perform day-to-day activities.
Evidently, the US Food and Drug Administration (FDA) has now granted approval for aducanumab, subject to the condition that people who are administered the drug would be part of a “phase 4” trial.
This would allow researchers to supposedly monitor these people and track their response to the drug and observe if it can successfully decline the progression of mental deterioration.
In November 2020, the FDA had apparently rejected the application for aducanumab. Three of the agency’s advisers reportedly wrote in a scientific journal about the lack of evidence for the drug’s efficacy.
Aducanumab, which is a monoclonal antibody, targets the accumulation of amyloid protein plaques inside the brain. These plaques are believed to be the cause of the Alzheimer’s disease and most drugs designed to treat the illness in the past have attempted to clear them.
It is worth noting that aducanumab seemingly clears these plaques in some patients although only in early stages of the illness. However, diagnosis at the early stage is challenging due to people’s reluctancy to test after experiencing memory loss and the widespread awareness of lack of treatment methods.
Source credits: https://www.theguardian.com/society/2021/jun/07/fda-announce-decision-new-alzheimers-drug-aducanumab