Monitoring Desk
WASHINGTON: The United State Food and Drug Administration approved a highly anticipated new drug on Friday that is designed to slow cognitive decline in patients in mild and initial stages of Alzheimer’s disease.
The approved drug, Leqembi, also known as lecanemab, comes just days after the regulatory agency was severely criticized in a congressional report for its green-lighting of another Alzheimer’s drug, Aduhelm.
And it was approved despite trial results showing the monoclonal antibody treatment carries risks of brain swelling and bleeding.
Both the drugs were approved through an accelerated procedure that allows the FDA to fast-track approval of drugs for grave conditions where there is an unmet medical need.
According to the FDA statement the two drugs Leqembi and Aduhelm, which were jointly developed by Japan’s Eisai and Biogen of the US, “represent a significant advancement in the ongoing fight to effectively treat Alzheimer’s disease.
Alzheimer’s Disease
Billy Dunn from the FDA’s Center for Drug Evaluation and Research said that Alzheimer’s disease immeasurably disables the lives of those who suffer from the disease and has devastating effects on their loved ones adding that Leqembi would be the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of just treating the symptoms of the disease.”
About 6.5 million Americans suffer from Alzheimer’s, disease which is characterized by memory loss and lessening mental acuity.
In September preliminary data from a trial of Leqembi was issued and found it slowed cognitive decline in Alzheimer’s patients by about 27 percent.
Meanwhile, the phase three trial involved nearly 1,800 people, divided between those given the drug and given a placebo, and ran over 18 months.
The comprehensive trial data, published in the New England Journal of Medicine, raised worry about the incidence of “adverse effects” including brain bleeds and swelling.
Accordingly, the results showed that 17.3 percent of patients administered the drug encountered brain bleeds, compared with nine percent of those receiving a placebo.
While 12.6 percent of those taking the drug witnessed brain swelling, compared with just 1.7 percent of those in the placebo group.
Deaths were recorded at approximately the same rate in both arms of the trial of the drug.
In Alzheimer’s disease, two important proteins, tau and amyloid beta, build up into tangles and plaques, known together as aggregates, which results in brain cells to die and lead to brain shrinkage.
Similarly, Leqembi, which is administered intravenously once every two weeks, works by targeting amyloid.
In the trial, patients getting Leqembi had a statistically significant reduction in brain amyloid plaque compared to the placebo arm, which had no reduction of amyloid beta plaque.
Biogen and Eisai previously brought Aduhelm to the market, but there was substantial controversy over whether it worked, and its approval in 2021 led to three high-level resignations in the FDA.
Meanwhile, a US congressional investigation said the accelerated approval procedure for Aduhelm, the first ever drug approved in decades to treat Alzheimer’s, was “rife with irregularities” as well as criticized both the agency and Biogen.
Price of the Drug
According to a congressional report the Cambridge, Massachusetts-based Biogen set an “unjustifiably high price” for Aduhelm of $56,000 a year.
Eisai said Leqembi would be available initially at $26,500 per year and estimated that 100,000 Americans could be getting the drug by three years from now.
Moreover, Joanne Pike, president and CEO of the Alzheimer’s Association, welcomed the approval of Leqembi but also concerned that its high cost could put it out of reach of most of the Americans, particularly if it is not covered by Medicare, the government health insurance program for the elderly.
