An FDA approval on Friday will slow cognitive decline in patients suffering from Alzheimer’s disease in the early stages and mild stages.
Just days ago, the FDA harshly criticized for giving the nod to another Alzheimer’s drug called Aduhelm after green-lighting Leqembi, also known as lecanemab.
A monoclonal antibody treatment approved despite the fact that it carries risks of brain swelling and bleeding in trials.
In both cases, the FDA approved the drugs through an accelerated approval process that allows fast-track approval of drugs for serious conditions.
According to the FDA, Leqembi and Aduhelm, which jointly developed by Eisai of Japan and Biogen of the United States, “are important advances” in the ongoing effort to treat Alzheimer’s disease.
Center for Drug Evaluation
The Center for Drug Evaluation and Research of the FDA said in a statement that Alzheimer’s disease impairs the lives of those affected and has devastating effects on their loved ones.
In an interview with Fox News, Dunn called Leqembi “the newest therapy to target and treat Alzheimer’s’ underlying disease process rather than just treating symptoms.”
Alzheimer’s disease affects approximately 6.5 million Americans, which results in memory loss and deterioration of mental function.
It has recently revealed that Leqembi slowed the cognitive decline of Alzheimer’s patients by 27% according to preliminary findings from a trial.
It involved nearly 1,800 participants over the course of 18 months, of whom nearly 1,800 received the drug, and the rest received a placebo.
There was concern about the frequency of “adverse effects,” including brain bleeding and swelling, as reported in the Journal of Medicine.
In a study carried out by the National Institutes of Health, 17.3% of patients receiving the drug experienced brain bleeds, compared with 9% of patients receiving a placebo.
12.6% of those taking the drug experienced brain swelling, while just 1.7% of those taking a placebo experienced it.
It found that the death rate approximately the same in both arms of the drug’s trial.
The causes of Alzheimer’s disease
Alzheimer’s disease is cause by abnormal accumulations of two proteins, tau and amyloid beta, which build up in plaques and tangles, causing brain cells to die and enlarging the brain.
Amyloid is targeted by Leqembi, which is administered intravenously nearly every two weeks.
A statistically significant reduction in brain amyloid plaque was observed in patients treated with Leqembi compared to patients who received placebo.
Before Aduhelm brought to market in 2021, Biogen and Eisai faced controversy over whether it worked, and three FDA officials resigned following its approval.
An investigation by the US Congress found that the approval process for Aduhelm, the first Alzheimer’s drug approved in decades, “riddled with irregularities.” Both the FDA and Biogen criticized for the approval process.
In the congressional report, Biogen said it was charging $56,000 a year for Aduhelm, which is an “unjustifiably high price.”
A three-year timeline suggests that 100,000 Americans will have access to Leqsebi by then. Initially, the drug is expect to cost $26,500 per year.
It was welcome by the Alzheimer’s Association’s president and CEO, Joanne Pike, that Leqembi had approve, but she expressed concern that its high cost might put it out of reach for most Americans, especially if it did not fall under Medicare, the government health insurance program.
“It is very apparent that the people living with this deadly disease today do not have the time to wait for a miracle drug or cure in the near future,” said Pike, in a statement.
