FDA Approves New Alzheimer’s Drug That Appears to Slow Down Disease

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The Food and Drug Administration officially approved an Alzheimer’s drug that is shown in clinical trials to slow down cognitive decline in their patients in early stages of the illness. The approval will offer patients hope after several failures to find an effective treatment, despite there having been reports of side effects with this new certain drug.

The drug, called Lecanemab, is set to be sold under the name Leqembi, and is a monoclonal antibody infusion that is given every 2 weeks. The FDA approves a drug for use in people with mild cognitive impairment or early-onset Alzheimer’s disease.

Leqembi was approved in an accelerated pathway that allows early approval for those promising new medications that “fill an unmet medical need.” Companies will then be required to conduct additional clinical trials in order to confirm the benefits of the drug or risk complete removal from the market. 

Leqembi Approved by FDA

The FDA stated that its decision to approve the new drug was based on a staged trial of 156 patients who had Alzheimer’s disease. Back in September, Eisai and Biogen,  the company that developed the drug, announced that a phase 3 clinical trial of 1795 patients found the drugs slowed cognitive decline in those who received it by 27% after 18 months. The FDA is expected to review the face 3 data as soon as possible. 

The FDA did note that this certain drug is not a cure; rather, it aims to slow down the progression of the disease by removing inserts in clumps of beta-amyloid from the brain. Experts did note that the benefit of the drug is small but stated that they are glad that patients will have additional time with family and other loved ones by taking the drug.

The medication, which is said to be taken bi-weekly, is expected to cost around $25,000 annually for one single patient, according to Ivan Cheung,  who is the U.S. chairman and CEO of Eisai. The Centers for Medicare and Medicaid Services limits coverage of drugs that Target amyloid in the brain, meaning updates of the medication may be limited at first.

Alzheimer’s is the 7th leading cause of death in the US, according to the Centers for Disease Control and prevention. Most of the drugs that have been approved by the FDA for the disease aim to help symptoms and do not actually slow down the progression of the disease.

Read More: Heartwarming Video Shows 6-Year-Old Boy Patiently Feeding Grandfather With Alzheimer’s

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