FDA Grants Full Approval to Leqembi, Advanced Alzheimer’s Medication with Unmatched Efficacy

**U.S. Officials Approve Alzheimer’s Drug Leqembi for Medicare Coverage**

The U.S. officials have granted full approval to the closely watched Alzheimer’s drug, Leqembi, on Thursday. This approval now allows Medicare and other insurance plans to cover the treatment for individuals with Alzheimer’s disease. The drug is an IV medication developed by Japanese drugmaker Eisai.

**Leqembi: A Breakthrough Treatment for Early Alzheimer’s Disease**

Leqembi has received conditional approval from the FDA in January based on preliminary results suggesting its effectiveness in clearing the brain plaque associated with Alzheimer’s disease. The recent approval comes after a comprehensive review of data from a larger study involving 1,800 patients. The findings confirmed that Leqembi can moderately slow cognitive decline in individuals with mild dementia caused by early Alzheimer’s.

**The Confirmation of Leqembi’s Efficacy**

The FDA’s neurology drug director, Teresa Buracchio, stated that the confirmatory study verifies the drug’s safety and efficacy for Alzheimer’s patients. However, the drug’s prescribing information will carry a warning about potential side effects, including brain swelling and bleeding. Similar side effects are seen with other plaque-targeting Alzheimer’s medications.

**The Impact on Medicare and Insurance Coverage**

Medicare, which provides healthcare coverage for the majority of Americans with Alzheimer’s, had previously declared that it would not cover Leqembi until it received full FDA approval. There were concerns that the cost of Leqembi and similar drugs could strain Medicare’s financial resources. Leqembi is priced at around $26,500 for a year’s supply of IV treatments every two weeks.

**Immediate Coverage by Medicare and Private Insurers**

Following the FDA’s full approval, Medicare administrator Chiquita Brooks-LaSure announced that the program will now cover Leqembi. However, Medicare recipients must be enrolled in a registry to monitor the drug’s real-world safety and effectiveness. Private insurers have also withheld coverage for Leqembi and a similar drug called Aduhelm until they receive FDA’s full endorsement. The FDA’s decision on full approval for Aduhelm is still years away.

**Implementation Challenges and Additional Requirements**

The introduction of Leqembi into the healthcare system may face several challenges. Doctors must confirm that patients have the specific brain plaque targeted by the drug before prescribing it. Nurses must be trained to administer the drug properly, and patients must undergo repeated brain scans to monitor potential side effects. These additional services and procedures come with extra costs for hospitals in addition to the drug itself.

**The Future of Leqembi**

Eisai has estimated that approximately 100,000 Americans could be diagnosed and eligible to receive Leqembi by 2026. The drug is co-marketed with Biogen, a company based in Cambridge, Massachusetts. Both companies are focused on ensuring that only appropriate patients receive Leqembi.

**Expert Opinions on Leqembi’s Effectiveness**

The efficacy of Leqembi has been a topic of debate among experts. The drug was studied in individuals with early or mild Alzheimer’s disease, and the results showed that those who received Leqembi experienced a slower decline in cognitive function compared to those who received a placebo. However, some experts argue that this delay may be too subtle for patients or their families to notice.


The full approval of Leqembi by U.S. officials marks a significant milestone in Alzheimer’s treatment. It provides hope for individuals with mild dementia caused by early-stage Alzheimer’s disease. Medicare and private insurers will now cover the cost of Leqembi, although additional requirements and implementation challenges may need to be addressed. The future of Leqembi and its impact on Alzheimer’s patients will continue to be closely monitored by healthcare professionals.

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