Approval Of Alzheimer's Drug: FDA Adviser Resigns

Approval Of Alzheimer’s Drug: FDA Adviser Resigns

One of the advisory committee members of the US Food and Drug Administration stated on Wednesday that he has resigned his position over the approval of aducanumab, an Alzheimer’s disease drug. 

FDA’s approval still rained in a controversy that the drug needed to be considered for further tests and studies to ensure its effectiveness. 

Approval Of Alzheimer’s Drug: FDA Adviser Resigns

The drug is supposed to be sold under the title Aduhelm after it receives FDA approval, though a significant number of objections remained on the side of members in the advisory Peripheral and Central Nervous System Drugs Advisory Committee. 

Approval Of Alzheimer's Drug: FDA Adviser Resigns

The pees who resigned from the advisory board are Dr. David Knopman, and he said on Wednesday that he resigned from the position as an act of protest against the approval.

He justified his resignation that he doesn’t want to receive future disrespectful treatment from the institute. He also said that he disagrees with the decision to approve aducanumab and people like him in the clinical care and clinical research worlds will simply need to learn to adapt to

 the new circumstances.

FDA advisors united by did that there was no sound evidence to support the approval of the drug but was given by infusion. As the drug was given in the initial stage of the disease, before the patients started to develop clear symptoms of dementia, it did not indicate anything helpful to support the approval of the drug. 

However, the company representatives who developed the drug, Biogen, after re-analyzing the data said that though there is no clear evidence of the effectiveness of the drug, it can be helpful for some patients.

Knopman’s resignation was initially reported by The Washington Post, and the later reports give hints to the resignation of another member of the committee, Dr. Joel Perlmutter.

The recent decision from FDA is its first-ever action since 2003 on the deadly disease. Since no cure is discovered for the disease, no current therapies or medications are proven to alter the conditions and symptoms of Alzheimer’s. At the same time, the Alzheimer’s Association of the country suggested that there are 6 million Americans who struggle to have dementia associated with Alzheimer’s disease.

The clinical research on the controversial drug also was stopped in 2019 by the authorities as the drug was found to be of no use in treating the disease. However, the drug manufacturers said that they could find the drug could bring a slower rate of decline in conditions and symptoms related to the disease when consumed in high doses.

It was last December the PCNS committee members were asked to vote for several questions to gather evidence on the efficacy of the drug. But none from the committee voted in favor of the approval of the drug, as they couldn’t find any effects on the brain even after consistent use of the drug. 

FDA’s decision became a controversy not, as usual, the institute ignored the advice of the committee, and proceeded with the approval. Those who support the institute’s decision said that the need for the drug is desperate, whereas the opponents remarked that the drug will cost $56,000 a year, bringing billions of profit to Biogen while it makes no difference in patients.

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