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The FDA Board rejected Biogen’s new Alzheimer’s drug



Government medical advisers harshly criticized a closely watched Alzheimer’s drug on Friday, concluding that there was not enough evidence that this experimental drug slows the disease of brain damage. .

The Food and Drug Administration’s panel of outside experts agreed that a significant study in patients did not provide “solid evidence” that the drug worked. Experts warned of many “red markers” with the data, which did not initially show any benefit until the analysis differed from subsequent results.

Dr. Joel Perlmutter, Washington University School of Medicine, said: “Treatment of Alzheimer̵

7;s is a huge, urgent and unmet need. “

He is one of eight panel members who voted against evidence of drugs; One person voted that the drug showed “strong evidence” and two members said they were undecided. The panel also rejected the record of the second study on the drug.

The FDA is not obligated to follow the group’s guidelines, but their negative opinion could severely affect the agency’s decision to green light this drug. The FDA is expected to make a decision in March.

The drug Biogen, called aducanumab, does not cure or reverse Alzheimer’s disease; the claim is that it modestly slows down the rate of decline. Current medications are only temporary relief of symptoms and no new options have emerged since 2003.

Much of the panel’s comment is disprove FDA’s position. Earlier in the day, the FDA’s director of evaluation released a brilliant review of the drug, calling the study data submitted by Biogen as “particularly compelling”, “positive” and “robust”. But an FDA statistician noted the flaws and inconsistencies in the results and potential safety issues.

“It seems that the audio and video on TV are out of sync,” said board member, Dr. Caleb Alexander of Johns Hopkins University.

Friday’s meeting came after months of skepticism about the drug, co-developed with Eisai Co. Japanese.

Drug makers halted two studies of their drug last year after disappointing results. But a few months later, the companies reversed course, announcing that a new analysis found the drug to be effective at higher doses, and the FDA advised that it could warrant approval.

More than 5 million people in the United States and more around the world suffer from Alzheimer’s. Current medications only temporarily alleviate symptoms, and the last one was approved almost two decades ago.

The consumer group Public Citizen warned that the drug would be very expensive and “could disrupt our healthcare system”, while also giving patients false hopes.

FDA’s review focuses on safety and effectiveness. But approval proponents, including the Alzheimer’s Disease Association, are pushing for needed decision-making.

What is Aportanumab?

Aducanumab aims to help remove harmful protein blocks called beta-amyloid from the brain. Other experimental drugs have done just that, but it does not make a difference in a patient’s ability to think, take care of himself or live independently.

It’s a biotech drug made from living cells, and such drugs are very expensive. There are no published price estimates for drugs that are administered intravenously once a month.

If the aducanumab is approved, it will be covered by Medicare, the government program for seniors. FDA and Medicare are prohibited from reviewing costs when reviewing a new drug or treatment.

Even being eligible for drugs can be expensive. It’s only been tested in people with mild dementia caused by Alzheimer’s or a less serious condition called mild cognitive impairment. To verify the diagnosis, the brain scan request costs $ 5,000 or more. Insurance companies including Medicare don’t pay for the scan because it’s unclear for their benefit, but that could change if the scan becomes a gateway to treatment.

Does it work? The evidence

In the past, the FDA often required two studies showing it to be safe and effective, but in recent years has relaxed that standard.

Each of the two aducanumab studies attracted about 1,650 people and was stopped halfway when it didn’t appear to be working. Biogen said that subsequent results showed that one study was positive at the highest dose; The second study is clearly negative. The company says an analysis from both studies on people who took the highest dose for the longest time showed benefit.

But there are many questions about the validity of such analyzes. Another complication: studies were changed after they were conducted to give some people higher doses. And the placebo group in the positive study was worse than the group in the negative study, which might help explain why the aducanumab appeared better when compared to that group.

The FDA’s review has dismissed most of the safety concerns, including brain swelling that occurs in a third of patients, often leading to discontinuation of the drug.

Mayo Clinic’s Dr David Knopman said in a pre-meeting interview, the FDA should request a third study to test the drug under ideal conditions and have a clear answer. He was on the FDA advisory board but didn’t attend Friday’s meeting because he helped lead a study. He and other doctors published a report in the journal earlier this week arguing against approval.

What does it mean for the patient?

Nearly a dozen Alzheimer’s patients, family members, and doctors have been calling for approval of the drug during the online meeting’s public comment, saying the move will bring hope to patients and promote the development of complementary therapies.

But any benefits from the drug “are relatively small,” said Dr. Eliezer Masliah, head of neurology at the US National Institute of Aging, commented before the meeting.

In the active study, the drug modestly slows the rate of mental decline – only 0.39 out of 18 points in thinking skills. How much it means about being able to live independently, getting to know family members or remembering things is not clear.

Amyloid-removing drugs may have to be combined with drugs with other brain functions and taken early enough before damage can occur, Masliah said.

If the drug is approved, the American Academy of Neurology calls on the FDA not to do widespread licensing, which could expose more patients to a drug that could be more harmful than helpful, and possibly “overwhelming health care system ”.

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