FDA approves new Alzheimer’s drug

Katherine Ellen Foley reports for Politico that the FDA just approved an Alzheimer’s disease drug that appears to show a small benefit to some people in the early stages of Alzheimer’s. That said, the drug, Leqembi, is expensive and comes with grave side effects for some people. For now, Medicare is not covering the drug, except for people in a Leqembi clinical trial.

Keep in mind that after the FDA approved Aduhelm, the government adjusted the Medicare Part B premium up $11 a month! It’s list price was $56,000 a year, and the government assumed hundreds of thousands of people would take it. Thankfully, Medicare did not end up covering it. And, this year, the standard Part B monthly premium is down $5.20 because the government adjusted it to account for the fact that Medicare is not covering Aduhelm.

Leqembi has now undergone three clinical trials to demonstrate clinical benefits, as required by the FDA for drugs approved through an accelerated process. The third trial shows modest clinical benefits and reduction of amyloid proteins in the brain. FDA approval is only for patients in the early stages of Alzheimer’s disease, with evidence of amyloid proteins in their brains.

Leqembi has a launch price of $26,500 a year. It is infused into a patient’s body every two weeks.

Eisai and Biogen manufacture the drug. These are the same companies that manufactured Aduhelm, which the FDA approved against the advice of its advisory committee. Medicare refused to cover Aduhelm, except in clinical trials, seemingly because of serious side effects and unremarkable clinical benefits.

About one in seven people in the Leqembi trial suffer side effects, including swelling and bleeding of their brains. At the same time, about one in nine people who received a placebo in the trial also suffered from brain bleeding and swelling.

Three people in the trial on Leqembi have died. It’s unclear whether Leqembi caused their deaths. Leqembi appears to reduce the rate of cognitive decline, though only by a modest amount. It also appears to keep Alzheimer’s-related proteins from gathering in the brain.

Here’s more from Just Care:

• New Alzheimer’s drug drives up Part B premiums
• What are your Medicare premium and other costs in 2023?
• 2023: Medicare Part D prescription drug coverage and costs
• What’s a durable power of attorney?
• What are the signs of dementia?