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FDA approval of new drug for Alzheimer’s disease may increase prospects for other treatments



Biogen approval by the Food and Drug Administration Inc.

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Aduhelm on Monday may have increased the prospects for other experimental drugs for Alzheimer’s disease that target the disease in a similar way.

In light of Aduhelm, the FDA has backed a hypothesis about Alzheimer’s disease, which was recently thought to be dead: the disease can be treated by clearing the accumulation of a sticky substance in the brain known as amyloid.

Many scientists studying Alzheimer’s disease are not ready to abandon the amyloid hypothesis, but there is no consensus on exactly what role amyloid plays in the disease.

In Aduhelm’s approval, the FDA said the drug reduced amyloid and thus likely helped Alzheimer̵

7;s patients.

The decision was welcomed by many groups of Alzheimer’s patients and doctors who did not have good treatment options. The move has been criticized by many researchers, who say there is not enough evidence to show that the drug worked and at a cost of $ 56,000 a year on the list, it would be expensive.

A new treatment for Alzheimer’s disease

The nutrient Aduhelm can help slow down the damage to the brain caused by degenerative disease.

How Alzheimer’s disease affects the brain

Prominent scientific theory states that in Alzheimer’s disease, naturally occurring proteins bind together in lumps called amyloid plaques. Accumulations accumulate around brain cells, disrupting their function and contributing to cognitive decline.

Aduhelm is a laboratory-produced antibody, an immune agent that protects the body from harmful substances such as viruses and toxins. Aduhelm is modeled on antibodies taken from adults with very slow or no cognitive decline that scientists have found to be specific for amyloid.

When injected into the body, Aduhelm antibodies attach to amyloid clusters in the brain and clear them from the brain, although scientists are not sure exactly how.

Aduhelm can clear amyloid from the brain through the bloodstream

It can also hire immune cells to absorb amyloid deposits

Prominent scientific theory states that in Alzheimer’s disease, naturally occurring proteins bind together in lumps called amyloid plaques. Accumulations accumulate around brain cells, disrupting their function and contributing to cognitive decline.

Aduhelm is a laboratory-produced antibody, an immune agent that protects the body from harmful substances such as viruses and toxins. Aduhelm is modeled on antibodies taken from adults with very slow or no cognitive decline that scientists have found to be specific for amyloid.

When injected into the body, Aduhelm antibodies attach to amyloid clusters in the brain and clear them from the brain, although scientists are not sure exactly how.

Aduhelm can clear amyloid from the brain through the bloodstream

It can also hire immune cells to absorb amyloid deposits

Prominent scientific theory states that in Alzheimer’s disease, naturally occurring proteins bind together in lumps called amyloid plaques. Accumulations accumulate around brain cells, disrupting their function and contributing to cognitive decline.

Aduhelm is a laboratory-produced antibody, an immune agent that protects the body from harmful substances such as viruses and toxins. Aduhelm is modeled on antibodies taken from adults with very slow or no cognitive decline that scientists have found to be specific for amyloid.

When injected into the body, Aduhelm antibodies attach to amyloid clusters in the brain and clear them from the brain, although scientists are not sure exactly how.

Aduhelm can clear amyloid from the brain through the bloodstream

It can also hire immune cells to absorb amyloid deposits

Approval could pave the way for FDA approval of other drugs for Alzheimer’s disease that reduce amyloid accumulation, including therapies studied by Eli Lilly & Co. and Roche Holding AG

, analysts say.

Shares in Lilly, which recently published promising results for its phase 2 donanemab, rose 10.2% on Monday. Shares of Roche gained 2.4% on Monday.

“The FDA has made the unproven claim that removing amyloid from the brain is enough to benefit Alzheimer’s patients, and with that understanding, other drugs that remove plaque should be approved,” said Ronnie Gall, a pharmaceutical analyst. products in Bernstein.

The FDA has cleared Aduhelm in its expedited approval path, which allows drugs to be placed on the market before they are finally shown to be of clinical benefit to patients.

The route is most commonly used for cancer drugs, such as Amgen Inc.

Lumakras lung cancer treatment, which the FDA cleared late last month based on the therapy’s ability to shrink tumors.

The FDA’s belief that amyloid clearance is likely to benefit patients may predict other treatments targeting a variety of disease-related targets, including tangled strands of a protein called tau, according to Alzheimer’s analysts and researchers.

“This takes into account the good things about the Alzheimer’s field and not only about amyloid treatment, but also about tau,” said Maria Carilo, chief research officer at the Alzheimer’s Association.

Critics of the FDA’s decision say it sends a bad message to drug developers that they can use data from clinical trials to get approval from regulators.

The agency approved Aduhelm based on clinical trials that Biogen stopped early after determining it was unlikely to be successful. The company later analyzed additional data from the studies to seek approval.

“The accelerated approval process is not intended for drugs with weaker evidence. You still have to have high-quality, rigorous testing, ”said Aaron Kesselheim, a professor of medicine at Harvard Medical School and a member of an FDA advisory committee that rejected Aduhelm’s approval last year. “In this case, the trials were stopped earlier and not completed,” and Biogen later found signs that the drug was working, he said.

The FDA’s advisory committee has not been asked to consider whether amyloid reduction is likely to provide clinical benefits to patients, a hypothesis still under discussion because of the large number of amyloid-targeted drugs that have failed in the past, Dr. Kesselheim said.

“There is no good evidence that amyloid depletion leads to significant changes in the clinical course of the disease,” says Dr. Kesselheim.

Some biotechnology analysts warn that the FDA’s flexibility over Aduhelm may not extend to other amyloid-targeted treatments, especially those that have not been shown to be as potent in clearing amyloid from the brain.

“Wall Street is very surprised and, I think, shocked by the approval, but they are not yet fully convinced that the FDA is open to widespread approval of many drugs for Alzheimer’s,” said Michael Ye, a biotechnology analyst at Jefferies. “This is the first step towards moving the bar, but every company needs to have a large set of data to convince the FDA of clinical efficacy.”

Aduhelm’s approval is likely to stimulate further investment in Alzheimer’s drugs, said Alfred Sandrock, Biogen’s executive vice president of research and development.

“This will be a catalyst not only for other drugs targeting amyloid, but also for other ways to innovate in Alzheimer’s disease in general,” says Dr. Sandrock. The early multiple sclerosis drug beta interferon was approved in 1993 with accelerated approval, and we now have more than 20 drugs approved for MS in the last 25 years alone. So it has happened before and I think it will happen again, “he said.

Aduhelm’s path to approval

Write to Joseph Walker at joseph.walker@wsj.com

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