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6 Jan, 2023 23:53

US regulator fast-tracks dementia drug

The FDA approved lecanemab for Alzheimer’s despite alarming side effects
US regulator fast-tracks dementia drug

The US Food and Drug Administration (FDA) on Friday fast-tracked  the approval of lecanemab, a drug to treat the early stages of Alzheimer’s disease. Made by Japanese drugmaker Eisai and Biogen and marketed as Leqembi, the drug allegedly delays cognitive decline caused by the disease, though trials have shown some alarming side effects.

While a clinical trial of lecanemab’s efficacy in early Alzheimer’s published in November found it slowed cognitive and functional decline better than a placebo, the researchers noted that it was “associated with adverse events” and recommended “longer trials” to “determine the efficacy and safety of lecanemab in early Alzheimer’s disease” – an unusual call for caution in a study co-funded by the drug’s manufacturers. 

Around 17% of those who took lecanemab experienced brain bleeding during the trials, while nearly 13% suffered brain swelling or effusions, compared to 9% and 2% in the placebo group respectively, according to the New England Journal of Medicine study. Some 7% of the trial participants stopped taking the drug due to the side effects.

Lecanemab’s high price point – $26,500 for a year’s worth of treatment – has also raised concerns. The Institute for Clinical and Economic Review suggested $20,600 as the price ceiling, arguing a cost-effective rate could be as low as $8,500. The company suggested it could lower the dosing frequency to cut costs.

Biogen is no stranger to controversy over its Alzheimer’s drugs. In 2021, several FDA board members resigned over concerns that Aduhelm, which the company had developed as the first drug designed to target the plaque buildup then believed to be the underlying cause of Alzheimer’s, had not demonstrated sufficient efficacy in treating moderate-to-severe dementia. While not a single member of the advisory panel responsible for reviewing the drug supported its approval, the FDA did so anyway, side effects and $56,000 annual price tag notwithstanding.

A congressional investigation that concluded last week found the approval process “rife with irregularities,” noting the FDA had “inappropriately collaborated” with the company it was supposed to be regulating.

Last year, it emerged that parts of the research that established the current plaque-based disease model of Alzheimer’s were possibly fraudulent, suggesting that the amyloid plaques found in the patients could be a symptom, rather than the cause, of the illness.