Friday, an Alzheimer’s drug that was shown in clinical trials to slow cognitive decline in patients in the early stages of the disease was approved by the Food and Drug Administration.
Even though there have been reports of side effects with the new drug, experts say that the approval gives patients renewed hope after repeated failures to find effective treatments.
Lecanemab is a monoclonal antibody infusion that will be sold under the brand name Leqembi and is taken every two weeks.
Leqembi was approved by the FDA for use in patients with early Alzheimer’s disease or mild cognitive impairment.
The drug was approved through an expedited process, which allows promising new medications that “fill an unmet medical need” to be approved quickly. In parallel, businesses are required to carry out additional clinical trials in order to demonstrate the advantages of their medicines or run the risk of having them pulled from the market.
The agency stated that a mid-stage Alzheimer’s disease trial with 856 patients served as the basis for its decision.
The drug’s developers, Eisai and Biogen, announced late in September that a phase 3 clinical trial of 1,795 patients found that Leqembi slowed cognitive decline by 27% after 18 months. On Friday, the FDA stated that it anticipates reviewing the phase 3 data “soon.”
Before controversially approving another Alzheimer’s drug developed by Biogen in 2021, called Aduhelm, the FDA did not consult its advisory committee.
Leqembi isn’t a treatment; By removing clumps of beta-amyloid from the brain, which scientists have long believed to be one of the main causes of the disease, it aims to slow the progression of the disease.
Experts claim that the benefit is insignificant, but anything that might allow patients to spend more time with their loved ones is beneficial.
Ivan Cheung, Eisai’s U.S. chairman and CEO, told NBC News that a single patient’s biweekly medication should cost about $25,000 annually. According to Cheung, the new medication may initially be limited due to coverage restrictions imposed by the Centers for Medicare and Medicaid Services for drugs that target brain amyloid.
The medication has been the subject of safety concerns. After the patients experienced brain swelling or bleeding, the medication may be responsible for at least three deaths.
Brain swelling was experienced by 12.6% of patients who received the medication, compared to just 1.7% of those in the placebo group, according to the company’s phase 3 trial data. Brain bleeding occurred in approximately 17% of patients who received the drug, compared to 9% in the placebo group.
According to Cheung, the business is still “confident” that the drug’s benefits outweigh its risks.
He stated, “The disease is devastating and brings with it a lot of emotional turmoil for all involved families.”
According to the Centers for Disease Control and Prevention, Alzheimer’s disease is the seventh leading cause of death in the United States. The majority of Alzheimer’s medications approved by the FDA target symptoms rather than slowing the disease’s progression.
