The Food and Drug Administration approved a new drug Friday in hopes it will be the newest tool in the fight to slow early cognitive decline in Alzheimer's patients.

The FDA granted accelerated approval to Lecanemab, an experimental drug that will be marketed as Leqembi and likely spark considerable interest from patients and physicians across the country.

"Alzheimer's disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones," Dr. Billy Dunn, director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, said in a statement.

"This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer's, instead of only treating the symptoms of the disease."

Studies of the drug were run by Eisai, a Japanese pharmaceutical company, under the FDA's accelerated approval pathway. The accelerated approval program allows for earlier approval of medications that treat severe conditions and "fill an unmet medical need" while the drugs continue to be studied in larger and longer trials.

Partnered with American company Biogen, which makes the controversial Alzehimer's drug Aduhelm, Eisai administered an intravenous infusion every two weeks — which suggested the drug's capabilities in slowing the advance of the disease outpaced other treatments.

Still, there are risks attached to the drug, as studies revealed safety concerns stemming from Lecanemab's association with certain serious adverse events, including brain swelling and bleeding.

Results from an 18-month Phase 3 clinical trial published in November by the New England Journal of Medicine, showed that Lecanemab "reduced markers of amyloid in early Alzheimer's disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events."

Amyloid beta is a hallmark of Alzheimer's disease, which Lecanemab, a monoclonal antibody, is able to bind to.

However, the clinical trials concluded that "longer trials are warranted to determine the efficacy and safety of Lecanemab in early Alzheimer's disease."

This warning comes on the heels of the conclusion of an 18-month investigation by two congressional committees, which found that the approval process for Aduhelm, a similar Alzeheimer drug, involved suspiciously close collaboration with Biogen, its maker.

The most common adverse events during the Lecanemab trials were reactions to the intravenous infusions and abnormalities on their MRIs, such as brain swelling and bleeding called amyloid-related imaging abnormalities, or ARIA, which can become life-threatening.

According to the FDA, "ARIA most commonly presents as temporary swelling in areas of the brain that usually resolves over time and may be accompanied by small spots of bleeding in or on the surface of the brain, though some people may have symptoms such as headache, confusion, dizziness, vision changes, nausea and seizure."

Lecanemab will carry a wholesale price of $26,500 per patient per year, the drug's manufacturers announced last week. The drug's cost is slightly below the reduced price of Aduhelm, which now costs an average patient about $28,200.

Last year, the federal Centers for Medicare and Medicaid Services limited Medicare coverage for Aduhelm, citing the treatment's unclear benefits and safety risks, and allowing payment only for participants in clinical trials. That meant very few patients could afford Aduhelm, effectively sidelining the drug from the marketplace.

In justifying the cost of Lecanemab, Eisai and Biogen said in a news release that based on the estimated quality of life gained by people who take it, the value of the medication to society is around $37,000 a year, but they chose to go lower "aiming to promote broader patient access, reduce overall financial burden, and support health system sustainability."

The FDA categorizes Alzheimer's disease as an irreversible, progressive brain disorder affecting more than 6.5 million Americans. Alzheimer's slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. While the specific causes of Alzheimer's are not fully known, it is characterized by changes in the brain, often detected through the use of MRIs.

Medicine