A new medication that aims to slow Alzheimer’s disease patients’ cognitive decline was approved by the US Food and Drug Administration (FDA). An expedited approval process was used to approve the new treatment, Leqembi or lecanemab. It comes after the FDA approved Aduhelm, an anti-Alzheimer’s medication that was criticized by a congressional investigation for alleged irregularities.
According to the US FDA, Leqembi and Aduhelm represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease. According to Dr. Billy Dunn of the Center for Drug Evaluation and Research at the US Food and Drug Administration, Alzheimer’s disease irreparably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones.
According to Billy Dunn, Leqembi is the most recent treatment for Alzheimer’s that treats the disease’s underlying process rather than just its symptoms. In September, preliminary results from a trial showed that Leqembi, or lecanemab, slowed Alzheimer’s patients’ cognitive decline by 27%. Over the course of 18 months, the phase three trial included nearly 1,800 participants.
Eisai Co. Ltd. in Japan and Biogen in the United States created the two medications. According to Eisai, the drug would go on sale for $26,500 per year. A congressional investigation in the United States found that the accelerated process for Aduhelm was fraught with errors and criticized Biogen and the FDA. Additionally, the report argued that Biogen charged an unreasonable annual price of $56,000 for the drug.
By removing clumps of the harmful protein beta amyloid from the brain, a class of treatments called leqembi aims to slow the progression of Alzheimer’s disease. Brain shrinkage is caused by these clumps, which kill off brain cells.