FDA to Decide on Approval of First Alzheimer's Drug Leqembi

Quincy Jon, Tech Times 06 July 2023, 01:07 pm

The US Food and Drug Administration (FDA) is expected to make a crucial decision about the traditional approval of the Alzheimer's medication Leqemb on Thursday. This ground-breaking medication is the first to show promise in halting the course of the memory-robbing condition.

If approved, the CMS would amend its coverage standards to make the medicine accessible to almost one million early-stage Alzheimer's patients, as reported by CNN.

Eisai and Biogen manufactured Leqembi, which was approved in January because it can get rid of Alzheimer's disease-related amyloid plaque buildup in the brain. However, the medication has only seen limited use because of CMS's prior coverage choice, per Action 5 News.

How does it work?

Healthcare systems have been getting ready for Leqembi's expected expanded usage. Every two weeks, the medication is given intravenously, and infusion facilities have made the appropriate preparations to handle a probable increase in patients.

Leqembi targets and combats specific proteins in Alzheimer's patients' bodies, reducing the disease's development. The medicine would be the first to be recognized in this way if the FDA were to approve it fully, per WRAL. According to the North Carolina Medical Society, the yearly cost of Leqembi therapy is around $25,000.

Benefits and Side Effects

If Leqembi wins conventional FDA clearance, the CMS has said it will increase drug coverage. But to get coverage, a physician's and the clinical team's participation in gathering data on practical effectiveness will be required.

Leqembi is only allowed for patients with moderate cognitive impairment or mild dementia, brain amyloid plaques, and early-stage Alzheimer's disease. Dr. Lawrence Honig, a neurology professor at Columbia University Irving Medical Center, believes that one-sixth of the over six million Americans with Alzheimer's are in this category.

Patients with advanced illness stages could not benefit as much from the medicine and might run higher safety risks. Leqembi does delay decreases in cognitive capacity and function by 27%, but Dr. Honig warns that it is not a cure. Future developments in therapy effectiveness are anticipated.

Leqembi does have adverse effects, and frequent brain imaging monitoring is necessary. About 13% of patients in the clinical research had brain swelling or bleeding, with potential risks being higher for specific genetic subgroups or those using blood-thinning drugs.

Aduhelm, a different medication intended to halt the course of Alzheimer's, has gained provisional approval, although its advantages have not yet been shown.