The American Food and Drug Administration (FDA) on Monday approved a drug for Alzheimer’s disease, the first in nearly two decades. This decision of the FDA has become controversial with experts saying that clinical trials of the drug had returned unsatisfactory.
There are 30 million people suffering from Alzheimer’s disease globally. Of them, about 6 million are in the US, where the drug has been approved for usage.
Developed by Biogen, the drug named Aducanumab is said to slow down the progression of Alzheimer’s disease that affects the functioning of the brain. The approval came following months of debate within the medical circles over the procedures in recommending its use for the debilitating disease.
The development of a drug to treat Alzheimer’s disease has been slow due to the lack of definitive proof of its working. (Getty)
What is Alzheimer’s disease and how does Aducanumab work?
Alzheimer’s disease is the most common form of dementia and contributes 60-70 per cent of the cases. According to the World Health Organisation (WHO), it is a syndrome in which there is deterioration in memory, thinking, behaviour and the ability to perform everyday activities.
Dementia is one of the major causes of disability and dependencies among older people worldwide. The disease has a physical, psychological, social, and economic impact not only on people who are suffering from it but also on immediate families.
The disease, categorised in three stages, is identified with symptoms such as forgetfulness, losing track of time, having increasing difficulty with communication, difficulty in recognising faces and experiencing behaviour changes that may escalate and include aggression.
Experts believe that the drug will reach about eight per cent of Americans with mild Alzheimer’s disease by 2025. (Photo: Getty)
Aducanumab, which will be sold under the brand name of Aduhelm, is a monoclonal (referring to cloning of unique immunity cell) antibody that reduces amyloid-beta, which is a protein that leads to plaque formation in the brain. Plaque formation happens due to the accumulation of debris in the brain from neuron breakdown. The drug works to slow the deterioration process of the brain by reducing this plaque formation. However, there is no evidence to support that the drug will help in memory recovery.
The drug is the first since 2003 to attack the biological underpinnings of the disease, instead of just postponing the symptoms.
Controversy: Insufficient data to support efficacy
The development of a drug to treat Alzheimer’s disease has been slow due to the lack of definitive proof of its working in memory recovery and reducing disease progression.
While Aducanumab has been approved by FDA, there has been a major controversy over the clinical trials conducted to test the drug. The approval was based on two phase-3 trials. While the first showed some improvement in patients, the second failed to show any benefit.
During the clinical trials of the drug, 40 per cent of the phase-3 trial participants, who received a higher dosage of Aducanumab, experienced brain swelling or bleeding. According to reports, most were either asymptomatic or had headaches, dizziness or nausea. However, no phase-3 participant died due to drug trial.
The disease, categorised in three stages, is identified with symptoms such as forgetfulness, losing track of time. (Photo: Getty)
Early in November 2020, the drug was denied approval after a marathon seven-hour long virtual meeting with the medical panel disagreeing with the claims. Ten out of 11 members of the federal panel of medical experts voted that it was “not reasonable to consider the research presented as “primary evidence of the effectiveness of Aducanumab for the treatment of Alzheimer’s disease,” the New York Times reported.
The approval is a departure from the FDA’s established process that requires two convincing studies before a drug is used. Scientists are worried that the decision could lower the standards required for getting a medical product approved. The FDA has now asked Biogen to conduct another clinical trial.
There is no evidence to support that the drug will help in memory recovery. (Photo: AP)
Soaring prospects for Biogen
The approval will bring massive financial gains for Biogen, which saw its shares gain 38 per cent after the nod to its drug. The company has said that it would charge an average of $56,000 a year per patient to use the drug which is going to be one of the best-selling pharmaceutical products in the world.
The company expects nearly 900 sites to be ready to administer the drug in the US alone. However, there are chances that the demand might exceed, creating a supply shortage. Experts believe that the drug will reach about eight per cent of Americans with mild Alzheimer’s disease by 2025, minting $7 billion in revenue for Biogen in the process.
The newly developed drug is likely to overshadow the five medicines previously approved to treat the brain condition in one way or the other. The existing drugs to treat Alzheimer’s disease are Aricept, Razadyne, Exelon, Namenda and Namzaric.