Medical experts divided on whether 2nd FDA-approved Alzheimer’s drug provides a

The Food Drug and Administration recently approved a drug that may help patients in the early stages of Alzheimer’s by slowing down the progression of the disease. In clinical trials, the drug called lecanemab reduced the rate of cognitive decline among participants.

But doctors and health experts are divided on whether the drug warranted an accelerated FDA approval. While some of them have praised the agency’s decision, describing the drug as groundbreaking, others are skeptical of whether it provides a substantial benefit.

In the U.S, over 6 million people are living with Alzheimer’s, an incurable and fatal disease that affects the brain and causes loss of cognitive function over time. While there are available medications that can treat Alzheimer’s symptoms, there have been no treatments that can address the underlying cause of the disease. This is why some doctors have welcomed the accelerated approval of lecanemab. The FDA is likely to consider a full approval later this year.

“We’re pretty excited that we finally have something,” Dr. Reisa Sperling, who directs the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital in Boston, recently told NPR.

Heather Snyder, vice president of Medical and Scientific Relations at the Alzheimer’s Association, told Yahoo News the organization “celebrates” the Jan. 6 approval of the drug. “This is now the second approved treatment that evidence suggests changes the course of Alzheimer’s disease in a meaningful way,” she said.

Lecanemab, which will be marketed as Leqembi, is the second Alzheimer’s drug to receive a fast-track approval by the FDA. This accelerated authorization is usually given to promising treatments targeting diseases for which there are no other effective options available. In the summer of 2021, the agency gave a similar drug called aducanumab, sold under the brand name Aduhelm, accelerated approval as well. But the move was controversial because the FDA approved the drug despite conflicting evidence about whether it provided a benefit to patients, and against the recommendation of one of its committees of outside experts.

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Aduhelm’s accelerated approval prompted a congressional investigation. Since then, the federal Medicare program has decided not to cover Aduhelm treatment for the general population, but only for patients who were enrolled in the clinical trial. Some hospital systems across the country have also declined to offer the drug to Alzheimer’s patients. Due to the controversy surrounding the drug’s efficacy and its high price, as well as the negative publicity it has received, few patients have gotten the treatment. As a result, many doctors who treat the disease have been left, once again, with limited options.

Snyder said that even though Leqembi is not a cure, by slowing the progression of the disease, the drug would give patients more time to enjoy aspects “of daily life.”

“That could be things like participating in a birthday party or going to a wedding, recognizing their spouse, their children, their grandchildren, their neighbors, and really that time is enabling an individual to also make decisions about their care as they go forward as well,” she said.

Like Aduhelm, the drug lecanemab was developed by Eisai in partnership with fellow drugmaker Biogen. These treatments are monoclonal antibody therapies that are designed to remove a substance called beta-amyloid from the brain. Beta-amyloid is a naturally occurring protein that becomes toxic when it clumps together and forms the sticky plaques that are a hallmark of Alzheimer’s disease.

The theory behind the development of monoclonal antibody treatments like lecanemab is that amyloid plaques cause the loss of brain cells that leads to cognitive decline in people who suffer from Alzheimer’s. By reducing the amount of amyloid plaques in the brain, these treatments are believed to help slow down the process of memory loss and cognitive decline.

In a clinical study of nearly 1,800 people in the early stages of Alzheimer’s, those who were given lecanemab for 18 months experienced 27% less decline in memory and thinking compared to those who received the placebo. Although the trial results were positive and unprecedented, some experts believe the excitement for the drug is not proportional to its apparent benefit.

“The clinical trial data shows a statistically significant but clinically undetectable difference in the outcome measure between active treatment and placebo over 18 months,” Dr. Michael Greicius, a professor of neurology and neurological sciences at Stanford University, told Yahoo News.

He said the accelerated FDA approval of lecanemab made sense because in clinical trials, the drug…