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FDA approves Alzheimer’s drug from Biogen polish expert advice

The Food and Drug Administration approved an Alzheimer’s drug on Monday. It’s the first time the agency has approved a new treatment for the disease since 2003. The move comes after an independent panel called on the agency in November to reject a drug called aducanumab. warns that no treatment has been shown to help slow the progression of the disease.

Aducanumab is the only drug administered by US regulators. indicates that the underlying disease can be treated Instead of managing symptoms such as anxiety and insomnia, Manufactured by Biogen in Massachusetts. and will be sold under the name Aduhelm.

such a decision This could affect millions of older Americans and their families. would inevitably cause conflicts between doctors medical researcher and patient groups There are also broad implications for standards used to evaluate experimental treatments. This includes only standards that show increased benefits.

Maria Carrillo, Chief Scientific Officer of the Alzheimer̵

7;s Association praised such approval as “A historic moment for our branch”

“The Alzheimer’s Association believes that approval will usher in a new era of Alzheimer’s treatment and even research,” she said. This treatment is meant to slow the decline.”

The FDA accepted arguments about the drug in a statement from Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

“There has been a lot of public debate as to whether Aduhelm should be approved or not. It is common to interpret scientific data. The expert community has offered different views,” she wrote, adding that “the information included in the applicant’s application is The uncertainties are highly complex and are left behind about the clinical benefits.”

During a media briefing on Monday, Cavazzoni explained that the drug was approved through the FDA’s accelerated approval path, a guideline that allows the FDA to approve a drug for a serious or life-threatening illness when it is “inappropriate”. “Shows that the agent has improved. endpoints considered to be reasonably predictive of a clinical benefit.”

In the case of Aduhelm The endpoint of the agent was a decrease in cerebral amyloid plaque. which is a protein group that is considered the hallmark of disease Reducing these microorganisms “There is a tendency to appropriately predict the clinical benefit of the drug,” she said.

But saying that the drug tends to reasonably predict clinical benefit. This does not mean that it is guaranteed to do so. As a result, drugs that are approved through the FDA’s accelerated pathway must continue to study drugs to verify their clinical benefits.

“If the clinical benefit is not confirmed or if the study is not conducted in a timely manner We may withdraw approval of this treatment,” Cavazzoni said.

Benefit must be confirmed

Dr. Jason Karlawish, co-director of the Penn Memory Center in Philadelphia. And site reviewers for clinical trials of the drug Biogen disagreed with the FDA’s decision.

“It will be a real challenge for patients, caregivers and physicians whether to prescribe or not,” he said. better.”

Still, Karlawish said he would prescribe aducanumab, but only “after speaking with patients and family members about the notable uncertainty surrounding whether the drug works or not.”

Biogen’s new drug co-developed with Japanese company Eisai isn’t mind-blowing. only slowing it down in one study.

The FDA is requiring drugmakers to conduct follow-up studies to confirm the drug’s benefits for patients. If the study fails to show efficacy The FDA can pull the drug from the market. Although the agency rarely does that.

The drug will cost $56,000 a year, according to Biogen. The drug is given as an injection every four weeks at a cost of $4,312 per dose, based on the mean weight of patients with mild cognitive impairment or mild dementia.

A preliminary analysis by one group found the drug would cost $2,500 to $8,300 a year to be of good value, based on “Small overall health benefit” suggested by company study The non-profit Institute for Clinical and Economic Review added that “any price is too high” if the drug’s benefits are not confirmed in follow-up studies.

Nearly 6 million people in the United States and many others People around the world suffer from Alzheimer’s disease, which gradually attacks areas of the brain that are essential for memory, reasoning, communication and basic daily tasks. in the final stages of the disease Those who suffer will lose the ability to swallow. global burden of disease which is the most common cause of dementia This is expected to increase as millions of baby boomers become more advanced in the 60s and 70s.

Aducanumab (pronounced “add-yoo-CAN-yoo-mab”) aims to help clear a harmful protein group called beta-amyloid from the brain. Other experimental drugs have done this before. But it didn’t make a difference in patients’ ability to think, take care of themselves, or live independently.

The pharmaceutical industry’s drug pipeline has been littered for years. by failing to treat Alzheimer’s disease It costs billions of dollars in research. The FDA green light is likely to revive investments in similar treatments that the drugmaker previously withheld.

The new drug is made from living cells, which must be given by infusion at a doctor’s office or hospital. The most common side effect is inflammation in the brain. But most of them do not cause permanent symptoms or problems.

The FDA drug review has become a flashpoint in a long-standing debate about standards used to assess treatments for difficult-to-treat conditions. Zymer and their families say the new treatment Even a small benefit is guaranteed. But many experts warn that giving green pills a dangerous precedent. By opening the door to safeguarding dubious interests.

The approval came despite a nasty assessment in November by the FDA’s panel of exogenous neurology experts. The group voted “no” on a set of questions whether an analysis of data from a single study submitted by Biogen found the drug to have efficiency or not

Biogen is based in Cambridge. Massachusetts Two drug studies were discontinued in 2019 after disappointing results suggest that aducanumab does not meet its goals of slowing mental and functional decline in Alzheimer’s patients. months later The company has reversed It announced that a new analysis of one study found the drug to be effective at higher doses. And the FDA has suggested that it should be reviewed. The company’s scientists say the drug’s initial failure was caused by some patients not getting the drug high enough to slow the disease progression.

But changing the dosage and the company’s after-fact analysis made the results difficult to interpret. This caused the suspicion of many experts. including those on the FDA’s board.

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