New Alzheimer’s Drug approved by FDA

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There’s new hope in the fight against Alzheimer’s disease.

In July, the Food and Drug Administration approved the Alzheimer’s treatment Leqembi. It was a pivotal decision that would expand access to the expensive drug for older Americans.

Medicare announced shortly after the FDA approval that it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, though several conditions apply. Leqembi is the first Alzheimer’s antibody treatment to receive full FDA approval. It is also the first such drug to receive broad coverage through Medicare.

We spoke about this treatment to Dr. Alireza Atri, the Director of Banner Sun Health Research Institute.

“It’s a first-of-its-kind treatment in many ways,” Dr. Atri said. “It’s got full approval because it removes and lowers the plaques in the brain that are contributing and causing Alzheimer’s.”

Although Leqembi is not a cure for Alzheimer’s, it does slow the progression of the disease.

“The appropriate time for this medication is when individuals have symptoms at the earlier stages,” Dr. Atri said. “In those stages, individuals can really function quite well, and having more time at those stages can be very meaningful for patients and families.”

The most common side effects of Leqembi are bleeding and swelling in the brain which usually goes away over time. Other side effects may include headache, confusion, dizziness, vision changes, nausea and seizures that occur with the swelling and bleeding.

“It really depends on the patients that’s been chosen properly,” Dr. Atri said. “Some patients may not actually qualify because they’re not in the right clinical stages or because already their MRI showed they’ve had some bleeding or a lot of damage to their blood vessels. There’s also some genetic risk involved with that.”

Leqembi is an infusion drug, meaning patients must go in every few weeks to get an I.V. and infusion. The cost of the drug may also be a concern, with Lequembi costing $26,500 annually without insurance.

To be eligible for coverage, patients must be enrolled in Medicare, be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia and have a physician who participates in a qualifying registry with an appropriate clinical team and follow-up care.

Dr. Alireza Atri/Director, Banner Sun Health Research Institute

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