“FDA Grants Full Approval to Novel Alzheimer’s Drug Despite Efficacy and Risk Concerns”

# US Officials Approve Alzheimer’s Drug, Opening Door for Insurance Coverage

**Washington** — US officials have granted full approval to a highly anticipated Alzheimer’s drug, Leqembi, paving the way for Medicare and other American insurance plans to cover the treatment for individuals with the debilitating disease. The Food and Drug Administration (FDA) endorsed the intravenous (IV) drug for patients with mild dementia and other symptoms caused by early Alzheimer’s disease. Leqembi is the first medication that has been convincingly shown to modestly slow the cognitive decline associated with Alzheimer’s.

## Breakthrough in Alzheimer’s Treatment

– The FDA granted full approval to Leqembi, an IV drug developed by Japanese drugmaker Eisai.
– The drug has been shown to slow memory and thinking decline by about five months in patients who received the treatment.
– Leqembi works by clearing a sticky brain plaque linked to Alzheimer’s disease.

## Safety Concerns and FDA Approval

– The drug’s prescribing information will include a warning about potential side effects, such as brain swelling and bleeding, which can be dangerous in rare cases.
– The FDA confirmed the drug’s safety and effectiveness through a review of data from a larger study involving 1,800 patients.
– FDA’s neurology drug director, Dr. Teresa Buracchio, stated that the confirmatory study verified Leqembi as a safe and effective treatment for Alzheimer’s disease.

## Medicare Coverage and Cost Concerns

– Medicare, the primary health coverage provider for the majority of Americans with Alzheimer’s, will now begin covering Leqembi following its full FDA approval.
– Medicare administrator, Chiquita Brooks-LaSure, announced that the program will cover the medication broadly while gathering data on its real-world safety and effectiveness.
– Concerns about the cost of new plaque-targeting Alzheimer’s drugs potentially overwhelming Medicare’s finances led to the delay in coverage.

## Implementation Challenges and Patient Eligibility

– Doctors need to confirm that patients have the specific brain plaque targeted by Leqembi before prescribing the drug.
– Nurses require training to administer the drug, and patients must undergo repeated brain scans to monitor for potential side effects.
– Hospitals and medical clinics have cautioned that it may take time to initiate treatment due to additional costs associated with imaging and administration services.

## Future Prospects and Patient Perception

– Eisai estimates that around 100,000 Americans could be diagnosed and eligible for Leqembi by 2026.
– Some Alzheimer’s experts argue that the drug’s benefits of slowing cognitive decline are subtle and may not be noticeable to patients or their families.
– However, federal health advisers believe the difference in decline could still be meaningful and recommended full FDA approval for Leqembi.

As the first drug to receive full FDA approval for Alzheimer’s treatment, Leqembi represents a significant breakthrough in the fight against this devastating disease. While concerns about safety and costs remain, the approval opens the door for insurance coverage and provides hope for individuals and families affected by Alzheimer’s.

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