Health advisors from the US Food and Drug Administration (FDA) have rejected the experimental drug for Alzheimer’s disease called aducanumab. This drug has been developed by the biotech firm Biogen. Experts at the FDA have heavily criticized the drug stating that there has been no strong evidence that the drug can reduce the brain-destroying disease. The panel of advisors has included a set of outside experts at the FDA. They claimed that in a pivotal study, patients have not shown enough signs of improvement through treatment with the drug. Experts have highlighted multiple red flags with the data, which has not shown any effect until another analysis has taken place. One of the panelists, Dr. Joel Perlmutter has said that an effective treatment for Alzheimer’s is a huge and urgent need for public health; however, approving a drug with weak data is going to shoot up the risk of delaying effective treatment.
Dr. Joel Perlmutter has been among those advisors, who have voted against the drug. One advisor has voted in favor of the drug and two others have said that they are unsure about the efficacy of the drug. The panel of health experts has rejected the merits of a second study on the drug as well. Although the FDA does not need to abide by the panel’s decision, however, the panel’s negative remarks can influence the agency’s decision to approve this drug. The FDA is supposed to make a decision on the drug by March 2021. The drug developed by Biogen does not cure Alzheimer’s. It only reduces the rate of cognitive decline. Other available treatments subside symptoms of the disease only. There has been no effective treatment for the disease since 2003. There have been two contradictory statements regarding the new drug within the agency itself. The FDA’s chief staff reviewer has said that the findings of the study have been exceptionally positive, whereas the panel of health experts has noted inconsistencies and flaws in the data of the study of the drug.
The FDA usually needs the findings of two studies to assess the efficacy and safety of the drugs, however, in recent times; the agency has relaxed its standard. Both studies on aducanumab have included nearly 1650 volunteers, but both have been abruptly stopped midway considering the ineffectiveness of the drug. The company Biogen has said that one study has shown positive results at the highest dose and the other study has turned out to be negative. The officials from the company have claimed that another analysis of people from both studies who have been given the highest dose has shown positive results. However, health officials have asserted that there are many limitations to this analysis as well. Both studies have been altered when they have been stopped to let people have the highest dose of the drug. The placebo group in the positive study as well has been deteriorated. One of the experts in the advisory panel of the FDA, Dr. David Knopman has said that the agency might need a third study to assess the drug in ideal circumstances to reach a conclusion.