FDA approval of the first new Alzheimer’s disease treatment in 17 years would go against the opinion of the vast majority of the experts it consulted.
The government today released the findings of an independent advisory panel that reviewed data on the antibody medicine candidate.
Aducanumab and found that not even the strongest available clinical trial data supported its effectiveness.
The FDA has been given until March 2021 to make a decision on aducanumab; traditionally, the agency has followed the recommendations of its advisory committees.
If approved, Biogen stands to make tens of billions of dollars off of aducanumab, which would be the first medicine prescribed to delay cognitive loss in Alzheimer’s patients.
This could also provide support for the hypothesis that removing the protein beta amyloid from the brain is an effective treatment for Alzheimer’s disease.
There is No Cure for Alzheimer’s Disease, and It Is Terrible
According to Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
“Alzheimer’s disease is a severe condition that can have a tremendous impact on the lives of persons diagnosed with the disease and their loved ones.”
This therapeutic option is the first medicine to target and alter the underlying disease process of Alzheimer’s, whereas existing therapies just treat symptoms of the disease.
Accelerated approval pathways can deliver medications to patients more quickly and encourage greater research and innovation, as we have seen in the fight against cancer.
It Gradually Decreases the Memory
Memory, thought processes, and finally the capacity to perform even routine tasks are all gradually and irreversibly eroded by Alzheimer’s disease, a degenerative and fatal brain ailment.
Amyloid plaques and neurofibrillary, or tau, tangles are hallmarks of Alzheimer’s disease, which is also defined by the loss of neurons.
And the connections between them. These alterations impair one’s capacity for learning and reasoning.
Antibody aducanumab was just approved by the FDA, marking the first novel treatment for Alzheimer’s disease in the US since 2003.
The U.S. Food and Medicine Administration (FDA) decided that the Biogen-created drug should be allowed on the market despite opposition from an advisory panel, a move that surprised many specialists.
Two big clinical trials were conducted to determine the drug’s effectiveness in preventing cognitive decline in patients, but the results were inconclusive, leading to the final judgement.