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(c) 2021, The Washington Post Laurie McGinley NATIONAL, HEALTH, SCIENCE-ENVIRONMENT, HEALTH NEWS 6/7/2021 – 11:35 a.m.

The Food and Drug Administration on Monday approved the first Alzheimer’s treatment to slow cognitive decline, a move likely to be welcomed by patients and advocates but harshly criticized by others who argued that there was insufficient evidence to support it the drug is working.

The drug called aducanumab is for people with mild cognitive impairment or early-stage dementia, both of which are caused by Alzheimer’s. It’s the first drug approved to change the course of the disease by slowing the deterioration in brain function – not just to relieve symptoms. Alzheimer’s treatment has not been approved since 2003, reflecting the extraordinarily high failure rate of drugs developed for the disease.

But alluding to the controversy surrounding the drug, the FDA is instructing the manufacturer, biotech giant Biogen, to conduct a post-approval study that confirms the drug works. The requirement, which is part of a program called accelerated approval, is designed to allow early approval of drugs that treat serious medical conditions and meet an unmet medical need.

In the months leading up to its approval, aducanumab was the subject of intense debate among researchers, doctors, patients, and advocates as to whether the drug would work – a consequence of the drug’s complicated history.

Proponents of the drug have predicted that FDA approval would spark new interest and investment in research into therapies for the progressive, terminal disease. Biogen says that by slowing the disease down, the drug gives patients valuable time to be with their families and do everyday chores like cleaning and shopping.

However, critics have argued that data on the drug’s effectiveness are weak and that FDA approval represents a dangerous lowering of standards in response to pressure from patients and stakeholders.

Intravenous treatment does not cure or reverse Alzheimer’s disease. And it could be priced as high as $ 50,000 a year per patient, making it a blockbuster product for the company and adding billions of dollars to the country’s health card.

The drug is a monoclonal antibody, a laboratory-made protein that can bind to substances – in this case, clumps of amyloid beta, a sticky plaque compound that many scientists believe may damage communication between brain cells and eventually kill them . Treatment is designed to trigger an immune response that removes the plaques.

Approximately 6.2 million Americans have Alzheimer’s, a number that is projected to more than double by 2050, barring breakthroughs in treatment, according to the Alzheimer’s Association. Depending on how the FDA writes the label, millions of people could be eligible for the drug, or at least for an evaluation of whether to take it.

Ronald Petersen, director of the Mayo Clinic’s Alzheimer’s Research Center, said in an interview before the FDA campaign that approval would be a “plus for our patients,” although the drug’s effects may be modest. He said the drug was “not a penicillin for Alzhiemer” and was referring to the discovery of a treatment for bacterial infections in the 20th century. Nevertheless, aducanumab is a “sensible therapeutic approach” that will likely be combined with other drugs in the coming years.

Jason Karlawish, a neurologist at the University of Pennsylvania’s Perelman School of Medicine, had a very different view. He wrote in a May 30 column for Stat News, a medical and health news site, that if approved, he would not prescribe aducanumab because the data were incomplete and the therapy had not been properly studied.

“Aducanumab is not the drug to usher in a new era in Alzheimer’s treatment,” he wrote.

Under the accelerated approval program, the FDA approves a drug but does not grant full approval until a post-marketing study confirms the drug works. The procedure is widely used for cancer drugs. If a study does not confirm its effectiveness, the agency can withdraw approval or change the labeling for the use of the medicine, although such measures are rare.

Aducanumab has seen several ups and downs. In 2019, Biogen half-halted two late-stage studies after an assessment found the studies were failing to meet their goals of slowing cognitive and functional impairment in Alzheimer’s patients. But in a sharp reversal, a company analysis published a few months later with additional data came to a different conclusion.

In one of the clinical studies, this analysis found that patients given the drug lost weight 22% more slowly than those given placebo. The other study failed, despite the company’s encouragement from data from a subset of study participants who received more of the drug. Biogen concluded that a key to effectiveness is giving patients a sufficiently high dose over a sufficiently long period of time.

However, critics said the dates were chosen to make the drug look better than it was. In a bitter meeting last fall, an FDA advisory committee recommended the drug’s approval and severely reprimanded the agency’s review staff for being so supportive of the drug and working closely with the company.

Three members of the advisory panel reiterated their opposition to approval in an article in the Journal of the American Medical Association in March. “There is currently no convincing evidence to support aducanumab’s approval,” they said. Critics also point out that the drug may have side effects – brain swelling and tiny bleeding in the brain, despite the fact that they were addressed in the study.

And they said approval would signal a harmful erosion of FDA standards. “This is a precedent that can be reused over and over, and it lowers the bar on Alzheimer’s data that others can jump over,” wrote John Carroll, editor of Endpoints News, a biotech journal, before the decision was made.

What outraged Biogen’s critics was the FDA’s strong support for the drug despite questions from the agency’s own statisticians.

The agency’s medical evaluators told the advisory committee in November that the only successful study was “extraordinarily convincing,” while the FDA’s own statistical review found the data inconsistent, saying that only a third study could show whether the drug works.

But supporters, including some but not all of the doctors who treat Alzheimer’s, and advocacy groups like the Alzheimer’s Association and UsAgainstAlzheimer’s, loved the news.

The approval supports the long-debated theory proposed in the early 1990s that fighting amyloid plaques may be an effective way to treat Alzheimer’s disease. Critics have complained that the focus on amyloid has pushed work on other important approaches, such as targeting a protein called tau or studying the role of inflammation.

Proponents counter that while multiple approaches should be pursued, aducanumab’s approval shows that anti-amyloid treatments can be beneficial when given early in the disease and used in high enough doses.

Biogen says it has 600 locations across the country that deliver the drug.

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