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FDA approves Aduhelm, new drug for Alzheimer’s disease for the first time in 20 years

For the first time in almost 20 years, the new drug for Alzheimer’s disease was approved by government health authorities on Monday. This decision ignored warnings from independent advisors that highly debated treatments have not been shown to help slow the progression of brain-destroying illnesses.

The Food and Drug Administration said it has approved a drug developed by Biogen for patients with Alzheimer’s disease. The scientific name for this drug, known as aducanumab, is aducanumab (pronounced “add-yoo-CAN-yoo-mab”).

It is the only drug that US regulators have said is likely to treat underlying illnesses rather than managing symptoms such as anxiety and insomnia.

This decision can affect millions of older Americans and their families and is certain to cause disagreements among doctors, medical researchers, and patient groups. It also has a wide range of implications for the criteria used to evaluate experimental therapies, including those that show only gradual benefits.

A new drug co-developed by Biogen with Eisai in Japan did not reverse mental weakness, but only delayed it in one study. The drug is given as an IV infusion every four weeks.

The FDA requires pharmaceutical companies to conduct follow-up studies to confirm the benefits of the drug to patients. If the study shows no efficacy, the FDA may withdraw the drug from the market, but the FDA rarely does.

From $ 30,000 to $ 50,000 per year

Biogen didn’t immediately reveal the price, but analysts estimate that the drug’s annual treatment costs will be between $ 30,000 and $ 50,000.

A preliminary analysis by a group found that drug prices need to go from $ 2,500 to $ 8,300 per year, based on the “small overall health benefits” suggested by a company study. .. The non-profit Institute for Clinical Economic Review added that “price is too high” if follow-up studies do not confirm the benefits of the drug.

About 6 million people in the United States and many more around the world have Alzheimer’s disease. Alzheimer’s disease gradually attacks areas of the brain that are needed for memory, reasoning, communication, and basic day-to-day operations. In the final stages of illness, suffering people lose the ability to swallow. The global burden of the disease, the most common cause of dementia, is expected to increase as millions of baby boomers move into their 60s and 70s.

Aducanumab (pronounced “add-yoo-CAN-yoo-mab”) aims to remove harmful masses of proteins called beta-amyloid from the brain. Other experimental drugs have done it before, but there was no difference in the ability of the patient to think, care for himself, and live independently.

New treatment?

The pharmaceutical pipeline in the pharmaceutical industry has been messed up for years with billions of dollars worth of research funding for failed treatments for Alzheimer’s disease. FDA approval could bring back investment in similar therapies previously shelved by pharmaceutical companies.

New drugs are made from living cells and need to be given by IV in a clinic or hospital. The most common side effect was inflammation of the brain, and in most cases there were no symptoms or persistent problems.

The FDA’s review of this drug has sparked a long-standing debate about the criteria used to evaluate treatments for difficult-to-treat conditions. On the one hand, a group of people with Alzheimer’s disease and their families say that any new treatment — even the slightest benefit — is worthy of approval. However, many experts say that approval of this drug is dangerous. It sets a clear precedent and warns that it may open the door to the treatment of suspicious interests.


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Approval was given despite a rigorous November evaluation by an external committee of FDA neurological experts. The group voted “no” to a series of questions about whether reanalytical data from a single study submitted by Biogen showed that the drug was effective.

Cambridge, Massachusetts-Biogen discontinued two studies of the drug in 2019 after disappointing results suggesting that aducanumab could not meet its goal of delaying the mental and functional decline of patients with Alzheimer’s disease. .. A few months later, the company reversed its policy and announced in a new analysis of one study that the drug was effective at high doses and the FDA advised that it needed to be reviewed. Company scientists said the initial failure of the drug was due to some patients who did not receive high enough doses to delay the disease.

However, dose changes and post-company analysis have made it difficult to interpret the results, creating skepticism among many experts, including members of the FDA committee.

FDA approves Aduhelm, new drug for Alzheimer’s disease for the first time in 20 years

Source link FDA approves Aduhelm, new drug for Alzheimer’s disease for the first time in 20 years

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