Government Approves New Alzheimer’s Drug For Use

Last Thursday, the FDA approved the new Alzheimer’s medication Leqembi, marking the first time a drug designed to slow the progression of Alzheimer’s disease has received full FDA approval, NBC News reported.

Leqembi, which was developed by US drugmaker Biogen and Japanese drugmaker Eisai, targets beta-amyloid, the protein in the brain long believed to be one of the underlying causes of Alzheimer’s.

In the phase 3 clinical trial among nearly 1,800 patients suffering from mild cognitive impairment or early-stage Alzheimer’s, the progression was slowed by 27 percent over 18 months.

Donna Wilcock, the University of Kentucky’s assistant dean of biomedicine, told NBC News that it is impossible to “understate the significance” of Leqembi’s approval.

Wilcock said that while the patients on the drug did still decline, the progression of the decline was slowed.

Mayo Clinic neurologist Dr. Ronald Peterson told NBC News that while Leqembi is not a cure for Alzheimer’s and does not stop the disease, it is a “first step” toward future therapeutics.

The Alzheimer’s Association, which advocated for Leqembi’s approval, welcomed the news.

In a statement last week, Alzheimer’s Association President Joanne Pike said the new drug could give those with early-stage Alzheimer’s “more time to maintain their independence” and “more months” in which they can recognize their spouses and families.

Biogen president Christopher Viehbacher celebrated the FDA’s decision, saying that it “marks a breakthrough” in Alzheimer’s treatment. He said Biogen and Eisai will be working on making Leqembi available “as soon as possible” to “eligible patients,” CBS News reported.

Teresa Buracchio, the acting director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research, said the decision to approve Leqembi was unanimous. She said the phase 3 trial verified that the drug “is a safe and effective treatment” for Alzheimer’s patients.