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

Approved by the Food and Drug Administration

Biogen Of a corporation

BIIB -0.12%

Aduhelm on Monday may have boosted the prospects for other experimental Alzheimer’s disease treatments targeting Alzheimer’s disease in a similar manner.

Aduhelm at the green light, The FDA has approved a hypothesis about Alzheimer’s disease. Thought dead: The disease can be treated by removing the buildup of sticky substances in the brain known as amyloid.

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

In approving Aduhelm, the FDA said the drug is likely to reduce amyloid and thereby help patients with Alzheimer’s disease.

The decision cheered from many groups of Alzheimer’s disease patients and doctors who lacked good treatment options. The move, however, lacked sufficient evidence that the drug worked and was $ 56,000 per year. Many researchers have criticized that the list price would be expensive.

New treatment for Alzheimer’s disease

The biogen drug Aduhelm may help delay the damage to the brain caused by degenerative diseases.

Effects of Alzheimer’s disease on the brain

According to well-known scientific theory, in Alzheimer’s disease, naturally occurring proteins combine to form a mass called amyloid plaque. The mass accumulates around the brain cells, disrupting the function of the brain cells and leading to cognitive decline.

Aduhelm is an antibody created in the lab, an immune agent that protects the body from harmful substances such as viruses and toxins. Aduhelm is modeled on antibodies taken from older people who have been found to be amyloid-specific by scientists and have very slow or no decline in cognitive function.

When injected into the body, Aduhelm antibodies bind to amyloid clusters in the brain and remove them from the brain, but scientists do not know the exact method.

Aduhelm may remove amyloid from the brain via the bloodstream

It may also mobilize immune cells to ingest amyloid deposits.

According to well-known scientific theory, in Alzheimer’s disease, naturally occurring proteins combine to form a mass called amyloid plaque. The mass accumulates around the brain cells, disrupting the function of the brain cells and leading to cognitive decline.

Aduhelm is an antibody created in the lab, an immune agent that protects the body from harmful substances such as viruses and toxins. Aduhelm is modeled on antibodies taken from older people who have been found to be amyloid-specific by scientists and have very slow or no decline in cognitive function.

When injected into the body, Aduhelm antibodies bind to amyloid clusters in the brain and remove them from the brain, but scientists do not know the exact method.

Aduhelm may remove amyloid from the brain via the bloodstream

It may also mobilize immune cells to ingest amyloid deposits.

According to well-known scientific theory, in Alzheimer’s disease, naturally occurring proteins combine to form a mass called amyloid plaque. The mass accumulates around the brain cells, disrupting the function of the brain cells and leading to cognitive decline.

Aduhelm is an antibody created in the lab, an immune agent that protects the body from harmful substances such as viruses and toxins. Aduhelm is modeled on antibodies taken from older people who have been found to be amyloid-specific by scientists and have very slow or no decline in cognitive function.

When injected into the body, Aduhelm antibodies bind to amyloid clusters in the brain and remove them from the brain, but scientists do not know the exact method.

Aduhelm may remove amyloid from the brain via the bloodstream

It may also mobilize immune cells to ingest amyloid deposits.

This approval may pave the way for the FDA to approve other treatments for Alzheimer’s disease that reduce amyloid accumulation, including therapies under study.

Eli Lilly

& Co., Ltd.

Roche Holding AG

Analysts say.

Lily shares, recently Announcing promising results Donanemab medications in the Phase 2 study rose 10.2% on Monday. Roche’s share price rose 2.4% on Monday.

The FDA has made an unproven claim that simply removing amyloid from the brain would benefit patients with Alzheimer’s disease. With that understanding, other drugs that remove plaque should be approved, “Bernstein said. Says Ronnie Gull, a pharmaceutical analyst at.

The FDA has approved Aduhelm under the Fast Track. This allows the drug to be put on the market before it is finally shown to have clinical benefits to the patient.

This route is most commonly used for anticancer drugs such as:

Amgen Of a corporation

Lung Cancer Treatment Lumakras Approved by FDA Liquidated at the end of last month It is based on the ability of the therapy to shrink the tumor.

According to analysts and Alzheimer’s disease researchers, the FDA’s acceptance that amyloid removal is likely to benefit patients targets a variety of disease-related targets, including entangled chains of a protein called tau. May be a good precursor to other treatments.

“It teaches us good things in the field of Alzheimer’s disease. It applies not only to amyloid-targeted treatments, but also to tau,” says Maria Carrillo, chief scientific officer of the Alzheimer’s Disease Association. ..

Critics of the FDA’s decision say it is sending a bad message to drug developers that substandard clinical trial data can be used for regulatory approval.

Agency approves Aduhelm based on clinical trials Biogen decided to discontinue early Did not seem to succeedThe company then analyzed additional data from the study to seek approval.

“The fast-track approval pathway does not cover drugs with weak evidence, but it still requires high-quality, rigorous testing,” said the FDA, a professor of medicine at Harvard Medical School who refused Aduhelm’s approval last year. Aaron Kesselheim, a member of the advisory board, said: “In this case, the trial was stopped early and did not complete,” Biogen later discovered signs that the drug worked, he said. Told.

The FDA’s advisory board was not asked to consider whether reducing amyloid could have clinical benefits for patients. This is a hypothesis that is still being discussed due to the large number of amyloid-targeted drugs that have failed in the past, says Dr. Kesselheim.

“There is not enough evidence that amyloid depletion results in meaningful changes in the clinical course of the disease,” says Dr. Kesselheim.

Some biotechnology analysts warn that the FDA’s flexibility for Aduhelm may not apply to other amyloid-targeted therapies, especially those that have not proven effective in removing amyloid from the brain. ..

“I think Wall Street is very surprised and shocked by the approval, but it’s still completely out of the FDA’s widespread approval of many Alzheimer’s drugs,” said Michael Yee, a biotechnology analyst at Jeffreys. I’m not sure. ” “This is the first step in changing the standard, but every company needs to have a large amount of data to convince the FDA of its clinical benefits.”

Aduhelm’s approval is likely to spur further investment in Alzheimer’s disease treatments, said Alfred Sandrock, Executive Vice President of Research and Development at Biogen.

“It catalyzes not only other amyloid-targeted drugs, but other ways to innovate Alzheimer’s disease in general,” said Dr. Sandrock. The early multiple sclerosis treatment, Beta Interferon, was approved under accelerated approval in 1993 and is now approved for more than 20 MS treatments in the last 25 years. So that’s what happened before and I think it will happen again, “he said.

Road to Aduhelm Approval

Write to Joseph walker joseph.walker@wsj.com

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

Source link FDA approval of new drug for Alzheimer’s disease may boost prospects for other treatments

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