Alzheimer's & # 39;  A hand holding a magnifying glass on an MRI of a patient's brain.

An MRI scan of the brain of a patient with Alzheimer’s disease. (Getty Images)

The Food and Drug Administration recently approved a drug to help slow the progression of the disease in early-stage Alzheimer’s patients. In clinical trials, the drug lecanemab slowed the rate of cognitive decline among participants.

But doctors and health experts are divided on whether the drug warrants accelerated FDA approval. While some applauded the agency’s decision, they described the drug as a new step, while others doubted that it would provide much benefit.

More than 6 million people in the US live with Alzheimer’s, a disease that affects the brain and causes cognitive decline over time. Although there are drugs to treat the symptoms of Alzheimer’s, there are no treatments that can treat the underlying cause of the disease. This is why some doctors have welcomed the accelerated approval of lecanemab. The FDA may consider full approval later this year.

“We’re so glad we finally got something.” Dr. Resa Sperlingwho directs the Alzheimer’s Research and Treatment Center at Boston’s Brigham and Women’s Hospital recently told NPR.

Heather Snyder, vice president of medical and scientific communications at the Alzheimer’s Association, told Yahoo News that the organization will “celebrate” the drug’s Jan. 6 launch. “It is now the second approved treatment that evidence suggests can meaningfully alter the course of Alzheimer’s disease,” she said.

Lecanemab, marketed as Leqembi, is the second Alzheimer’s drug to receive fast-track approval by the FDA. This accelerated approval often offers promising treatments targeted at diseases for which there are no other effective options. In the year In the summer of 2021, the agency granted aducanumab, a similar drug sold under the brand name Aduhelm, also fast-tracked approval. But the move was controversial because the FDA approved it despite conflicting evidence that the drug offered benefits to patients and against the recommendations of one of its committees’ outside experts.

Aduhelm’s expedited approval prompted A Congress investigation. Since then, the federal Medicare program has decided not to cover Aduhelm treatment for the general population, but only for patients enrolled in a clinical trial. Some hospital systems across the country also refuse to offer it. The drug for Alzheimer’s patients. Due to controversy over the drug’s effectiveness and cost, as well as negative publicity, few patients received the treatment. As a result, many doctors treat the disease, again, certain options are taken.

Snyder said that although Lexambi is not a cure, it slows the progression of the disease and gives patients more time to enjoy “everyday life.”

“It could be things like attending a birthday party or going to a wedding, recognizing their spouse, their children, their grandchildren, their neighbors. Well,” she said.

A single-dose vial with the drug packaging.

Lecanemab, marketed as Leqembi, received accelerated approval by the FDA on January 6. (Isaiah via Reuters)

Like Aduhelm, the drug Licanumab was developed by Isaias in collaboration with other drug maker Biogen. These treatments are monoclonal antibodies designed to remove beta-amyloid from the brain. Beta-amyloid is a naturally occurring protein that clumps together and becomes toxic and forms the sticky plaques that are the hallmark of Alzheimer’s disease.

This is the rationale behind the development of monoclonal antibody therapies such as lecanumab. Amyloid plaques It is caused by the loss of brain cells that lead to cognitive decline in people suffering from Alzheimer’s. By reducing the amount of amyloid plaques in the brain, these treatments are believed to help slow the process of memory loss and cognitive decline.

In a clinical study of nearly 1,800 people with early stage Alzheimer’s, those given licanemab for 18 months had a 27 percent reduction in memory and memory compared to those who received a placebo. Although the test results are positive and unprecedented, some experts believe that the excitement for the drug is not proportional to the benefits.

“The clinical trial data showed a statistically significant, but not clinically detectable, difference between active treatment and placebo at 18 months on the outcome measure,” said Dr. Michael Grecius, professor of neurology and neurological sciences at Stanford University.

The accelerated FDA approval of lecanumab makes sense because in clinical trials the drug has been shown to influence disease-related biomarkers. In this case, the biomarker is the reduction of beta-amyloid in the brain. “Lecanumab definitely removes amyloid plaques,” Gracious said.

But some experts fear that lecanumab’s approval will encourage drug companies to focus on therapies that target amyloid plaques and ignore other treatments that may be more fruitful.

“I consider it a game changer, but in a negative way, in how it changes the clinical and research landscape around Alzheimer’s disease,” Gracious said.

The new drug, given by intravenous injection every two weeks, is expensive. The companies that make the drug say they make $26,500 a year. So far, the Centers for Medicare and Medicaid Services (CMS) have. They said it will not cover the medicineAnd until it gets full FDA approval that can’t be changed.

“What CMS is doing by limiting coverage to approved treatments is unprecedented,” Snyder said. “It’s not something we’ve seen before and it’s wrong.”

If CMS ultimately decides not to cover lecanemab, Gracious said, the drug could be used but not very widely, because it would have to be paid for out of pocket.

He noted that there are some safety concerns about lecanumab, especially with other drugs that remove most amyloid plaques from the brain, which can cause a condition known as ARIA, or amyloid-related imaging abnormalities. Two types of ARIA include brain swelling and hemorrhage.

in the lecanemab studyMore than 12 percent of people who took the drug had brain swelling, and more than 17 percent had bleeding problems. Although few participants experienced complications, at least three people died related to the drug, although those patients appeared to have additional risk factors.

But Snyder said these side effects should not be a reason for doctors and patients in the early stages of the disease not to consider the drug.

“It’s important to remember this, Alzheimer’s is fatal … and all treatments have side effects,” she said. “So it’s very important that we manage and understand those and that an individual makes any treatment decision – not just with this drug or this disease, but across the board – weighing the potential benefits and risks.” [in] A conversation with their doctor.”

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