Leqembi: A Landmark Drug in the fight against Alzheimer’s disease receives full FDA approval

The U.S. Food and Drug Administration (FDA) has given traditional approval to Eisai and Biogen’s Alzheimer’s drug, Lecanemab, known under the brand name Leqembi, following an earlier accelerated approval, as reported by CBS News. This announcement on Thursday marked a significant step forward in Alzheimer’s disease treatment, marking the first time a drug directly addressing the disease’s underlying biology has been clinically validated.

Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, heralded the move as the first verification of a drug’s ability to demonstrably benefit the progression of this devastating disease. Leqembi is indeed the first known medication to slow Alzheimer’s progression, including memory and cognitive decline, by directly targeting the disease’s underlying biology.

Biogen president and CEO, Christopher A. Viehbacher, described this development as a breakthrough in Alzheimer’s treatment, which was previously deemed untreatable. Eisai and Biogen are working diligently to make Leqembi accessible to eligible patients, who include those in the early stage of dementia and Alzheimer’s, or those with mild cognitive impairment.

CBS News’ chief medical correspondent, Dr. Jon LaPook, clarified the drug’s usage parameters, indicating it’s not designed for those in the advanced stages of the disease. Moreover, he stressed that the treatment must be administered in a timely manner to be effective. He also noted that patients would need to show evidence of amyloid in their brains, detectable through brain scans or blood tests. Lecanemab, an antibody, not only removes existing plaque but also prevents plaque from forming, offering a potential avenue for Alzheimer’s prevention.

The FDA’s initial approval in January was rooted in a mid-stage study on 800 people displaying early Alzheimer’s signs. Later, Eisai published a larger study involving 1,800 patients, the results of which were assessed as part of the full approval process. This study examined patients’ progress on an 18-point scale measuring memory and other cognitive functions. It showed a less than half-point difference after 18 months, igniting debate over the drug’s efficacy.

However, the committee unanimously confirmed the drug’s benefit, noting it as a safe and effective treatment for Alzheimer’s patients. Dr. Joy Snider, a neurologist at Washington University in St. Louis, emphasized that while the drug is not a cure, it does slow disease progression, potentially giving patients an additional six months to a year of independent functioning.

Leqembi, administered via twice-a-month infusions, is not without its drawbacks. Potential side effects include brain swelling, infusion-related reactions, and headaches. Furthermore, the drug’s access is constrained by its substantial price tag – approximately $26,500 per year without insurance.

Chiquita Brooks-Lasure, head of the Centers for Medicare and Medicaid Services, pledged to cover this medication broadly while continuing to gather data on its effectiveness. Full FDA approval was a prerequisite for coverage extension, making the drug more affordable for many.

The FDA defines Alzheimer’s as an irreversible, progressive brain disorder, affecting more than 6.5 million Americans. It slowly eradicates memory and thinking skills, eventually rendering the individual incapable of performing simple tasks.

The Leqembi approval follows a controversy surrounding the FDA’s handling of another Alzheimer’s drug, Aduhelm, also developed by Biogen and Eisai. Despite warnings from independent medical advisors about its effectiveness and potential risks, Aduhelm was approved in 2021. The FDA subsequently updated its label to significantly limit its usage.

In contrast, Leqembi appears to offer a new horizon in Alzheimer’s treatment, moving beyond merely symptom management to impact the disease’s underlying process. Although not a cure, its potential to slow the progression of this debilitating disease offers a glimmer of hope for millions affected worldwide.