Doctors and scientists are urging the Food and Drug Administration to have an expert panel review safety concerns over a new Alzheimer's treatment by Japanese drug maker, Eisai. Lecanemab, the drug in question, won fast-track approval by the FDA in January despite reports of three patient deaths during clinical trials.

According to Axios, this is the latest concern over whether the FDA is cutting corners evaluating Alzheimer’s drugs following its controversial 2021 approval of Biogen’s Aduhelm, which proved to be a commercial failure when Medicare failed to approve the medication in patients who were not in clinical trials. The approval for Aduhelm was given even after an advisory panel objected, saying that there was no evidence the drug slowed the decline of memory and brain function. The concern is that the FDA’s swift decisions undermine medical standards and give patients false hope as in the current case with the new treatment, lecanemab, that also attacks amyloid plaque buildup in the brain.

Some health experts say that the agency is repeating the same mistake by not investigating the three deaths linked to lecanemab that is being marketed as Leqembi. Clinical trial results published in The  New England Journal of Medicine January 5 found that the drug “reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with averse events.” The study authors suggested “longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.”

The FDA did not follow its customary procedure and convene an advisory panel before the accelerated approval of the drug last month, says Axios.  Accelerated approvals are based on variables that suggest a drug probably works, rather than clinical results. Last year, congress gave the FDA more authority over the trials that are supposed to prove the drug works.

But some health experts say that the FDA should convene a public discussion on Eisai’s drug, which the manufacture says would cost $26,000 annually for the average patient, before giving its full approval. While the clinical trial results did show that it can slow the progression of Alzheimer’s by 27%, as well as slow the rate of cognitive decline over the 18 months period of the trial, the adverse events were significant.

In a press release, Doctors for America’s FDA Task Force called upon the FDA to put patients first and commit to holding an advisory committee before any decision is made on the full approval of the drug.

“The approval of lecanemab is based on secondary, unvalidated surrogate endpoint, but critical questions remain as to whether the benefits outweigh the risks of brain swelling, brain bleeding, and death among patients who received the drug,” said Doctors for America, adding that the FDA “must recognize the public need for greater transparency and scrutiny around its dealing with pharmaceutical companies and interest groups.

“Patients and doctors across the country want and need a cure for Alzheimer’s disease, not a false hope with a $26,000 price tag.”

Eisai researchers say that Alzheimer’s patients are willing to take those health risks if it means slowing down the progression of the disease. “They are willing to risk a brain hemorrhage,” said Sharon Cohen, one of the principal investigators.

Interestingly, the FDA approved lecanemab without reviewing the NEJM study and said that while “not submitted to the agency for review,” the study appears to support the drug’s clinical benefit. Some experts called this “jumping the gun,” adding that “talking about the clinical trial data that they have yet to review was alarming to see,” says Axios.