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New Alzheimer’s Drug Leqembi Gets FDA Approval

A good number of our clients and their loved ones are coping with Alzheimer’s Disease. Our job as elder law attorneys is to help them deal with the complex legal and financial challenges the diagnosis presents. While there is still no cure for the disease, as of July 6 there has been a modest breakthrough: The FDA gave full approval to Leqembi, a drug that appears to slow down the progression of the disease in those with early stage Alzheimer’s. An estimated 1.5 million Americans fit that profile.

Leqembi reduces the beta-amyloid plaques found in the brains of Alzheimer’s patients. In clinical trials, the drug slowed down the decline in memory and thinking by about 27% after 18 months of treatment. Sanjeev Vaiskavi, director of clinical research at Penn Memory Center, says the drug “may slow down progression of the disease and may give people more meaningful time with their families.”

If you think you may qualify to receive the drug, your doctor will need to test to confirm the presence of amyloid plaques. Leqembi is administered via intravenous infusion every two weeks. Since brain swelling and bleeding are potential side effects, you will have to seriously consider the possible benefits and risks before proceeding. Periodic brain scans will also be necessary.

The annual cost for the drug is estimated at $26,500. The good news is that on the same day the FDA  approved Leqembi, Medicare announced it will cover 80% of the cost. The $6,600 difference may be covered by your supplemental Medicare insurance, or would have to be paid out of pocket. However, the total annual cost of Leqembi treatement could go as high as $90,000, once regular doctor’s visits and periodic brain scans are factored into the cost.

Leqembi was developed by Biogen and the Japanese pharmaceutical company Eisai.

Click here for more information about Leqembi.

Click here for a handbook on steps to take when you or a loved one have been diagnosed with Alzheimer’s Disease.

Update 7/17/23: Eli Lilly has also developed a drug that is believed to modestly slow cognitive decline in those with early stage Alzheimer’s.  Like Leqembi, Donanemab targets beta-amyloid plaques. Donanemab has been submitted for approval to the US Food and Drug Administration. Lilly’s senior medical director John Sims says he expects to hear back from the FDA by the end of this year. More information here.