The FDA has moved forward with approving another drug despite its dangers.
In June 2021, the American Food and Drug Administration (FDA) approved Aduhelm (aducanumab) as the first medication for Alzheimer’s. The decision was met with severe criticism and opposition from experts, especially since the medication hadn’t shown any benefit or improvement in patients, but the FDA powered through with its decision, nonetheless.
Earlier this month, the FDA did it again with Lecanemab, which will be marketed as Leqembi. The drug will be the second Alzheimer’s medicine in the market thanks to FDA’s approval. Unfortunately, while Leqembi boasts more cautionary language on its label than Aduhelm when it debuted, the safety concerns are still mounting. The drug while shown to be moderately effective for the early and mid-stages of the disease could also cause the brain to swell and bleed. The medication became available in late January, but most patients will have to be placed on month-long waiting lists before purchasing the drug.
Alzheimer’s is a common type of dementia and is a neurological disorder that causes shrinkage or atrophy in the brain cells. A continuous and progressive decline in thinking, social and behavioral skills, memory, and language characterize it. The cause of the disease is unknown, and researchers only know that factors such as age and family history might affect its occurrence in patients.
Eisai, a Japanese pharmaceutical company, and its American partner Biogen developed and tested the drug that is now the talk of the town. Biogen is the company that manufactured the highly controversial Alzheimer’s medication Aduhelm. Leqembi targets and removes beta-amyloid, a protein that accumulates in brain-clogging plaques and is a major indicator of Alzheimer’s. The specificity of its target is perhaps one of the reasons why the drug has shown some improvement in early and mid-stage Alzheimer’s patients. In
contrast, other amyloid-targeting medications have shown poor results. This is according to Dr. Sam Gandy, an Alzheimer’s specialist at Mount Sinai Hospital.
The medication will cost $26,500 per year, slightly less than Aduhelm but still significantly not affordable, especially since it is higher than recommended by some analysts. In an 18-month trial with about 1,800 participants, Leqembi was shown to postpone the aggravation of early-stage Alzheimer’s by about 5 months. However, the marked improvement is only half a point more on a test of cognitive and functional skills as opposed to those who received fake or dummy versions of the medication during the trial.
A report on the findings from the trial, published in the New England Journal of Medicine concluded that “longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.” While some argue that the improvement is too minor to be credited, others contend that slowing the disease in its onset, before mental faculties deteriorate is crucial.
As with other amyloid-targeting medications, Leqembi can cause minor brain bleeding or brain edema. In the Eisai drug trial, 13% of its participants were reported to have edema, while 17% had brain bleeds. The symptoms of brain swelling, and bleeding could be mild headaches and blurred vision, or they may be severe. Two of the trial participants who were on blood thinners died during the trial. However, Eisai reported that their deaths couldn’t be linked to the medication.