FDA approves breakthrough Alzheimer’s drug Lecanemab

Lecanemab, a breakthrough drug to treat Alzheimer's, was approved by the FDA.

The drug is administered through an IV and targets amyloid in the brain.

Lecanemab works with the immune system to clearamyloid from the brain.

The director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research saidAlzheimer's disease incapacitates the lives of those who suffer from it and has devastating effects on their loved ones The latest therapy to target and affect the underlying disease process of Alzheimer's is the treatment option.

Lecanemab reduced markers of amyloid in early Alzheimer's disease and resulted in moderately less decline on measures of cognitive and function than placebo at 18 months but was associated with adverse events.

The most common side effects of the drug were headaches. headaches, confusion, dizziness, vision changes and nausea are some of the symptoms. Some patients in the trial had headaches.

More than 30 years ago, a British geneticist named Sir John Hardy discovered the significance of amyloid in Alzheimer's.

Lecanemab can be given via a bag every two weeks if a physician recommends it.

The drug is being reviewed to see if it will be covered by Medicare, the national healthcare system for seniors who are most at risk for Alzheimer's.

According to the Institute for Clinical and Economic Review, Lecanemab needs to be priced less than $20,600 a year to be cost-effective.

Only one drug has been found to be effective in treating Alzheimer's. The first therapy to show that removing amyloid is likely to reduce decline in cognitive function is Aducanumab. The scientific community has criticized the approval of these drugs due to their fast approval.

The FDA approved Aducanumab, which is marketed as Aduhelm, and Lecanemab on an accelerated timelines, both of which would normally take years to be approved.

Fast-track approval can be given to certain drugs if they are for serious diseases with few treatments. Health experts don't agree on whether Aducanumab slows down the disease. Unless the patient is in an approved clinical trial, Medicare won't pay for Aducanumab.

The Alzheimer's Association requested full and unrestricted coverage for FDA approved Alzheimer's treatments from the Centers for Medicare and Medicaid Services.

More than 6 million Americans are affected by Alzheimer's. In order to find out if someone is at risk for developing Alzheimer's, a Positron Emission Tomography Scan can be done, but it can cost thousands of dollars and Medicare doesn't cover it. The painful nature of the test deters many people from taking it.