FDA approves new drug to treat Alzheimer’s disease

A new drug to treat Alzheimer’s disease was approved by the US Food and Drug Administration on Tuesday.

In clinical trials, donanemab (Kisunla) modestly slowed the rate of thinking decline in patients in the early stages of memory-robbing disease. But it also carried significant safety risks, including swelling and bleeding in the brain.

“Kisunla showed very significant results for people with early symptomatic Alzheimer’s disease, who urgently need effective treatment options. We know that these drugs have the greatest potential benefit when people are treated earlier in their disease, and we are we work hard in partnership with others to improve detection and diagnostics,” said Anne White, executive vice president and president of Lilly Neuroscience, in a company news release announcing the approval. “Every year, more and more people are at risk of this disease and we are determined to make life better for them.”

Alzheimer’s advocates applauded the approval.

“This approval marks another step forward in developing the standard of care for people living with Alzheimer’s disease that will ultimately include an arsenal of new treatments, providing much-needed hope to the Alzheimer’s community,” Dr. Howard Fillit, co-founder and chief science officer. officer at the Alzheimer’s Drug Discovery Foundation, Lilly said in the news release. “Diagnosing and treating Alzheimer’s earlier than we do today has the potential to significantly slow the progression of the disease, giving patients invaluable time to maintain their independence for longer.”

Kisunla is similar to another drug, Leqembi, approved for the treatment of Alzheimer’s last year. Both attack the amyloid protein, which is involved in the development of Alzheimer’s, and both slowed dementia by several months. Leqembi is given every two weeks, while Kisunla is given monthly as an intravenous infusion.

Kisunla has another significant difference that is likely to appeal to patients and doctors: The drug can be discontinued after it clears all the amyloid plaques from the brain.

“Once you’ve eliminated the target you’re going after, then you can stop the dose,” White said, adding that this can reduce the cost and inconvenience of treatment, as well as the risk of side effects.

In the company’s trial, 17% of patients taking donanemab were able to stop the drug at six months; 47% stopped within a year; and 69% stopped within 18 months. Importantly, their cognitive decline continued to slow even after they stopped.

The treatment won’t come cheap, though: Kisunla’s list price will be $32,000 a year. The drug costs $26,000 a year, but is continued after all the amyloid is cleared.

About a quarter of those who received donanemab experienced swelling or bleeding in the brain. While most cases were mild, approximately 2% were serious, and side effects were associated with the death of three patients.

With both drugs, patients at highest risk include those who have had more than four microscopic bleeds in the brain and those with an Alzheimer’s-related gene variant called APOE4 — especially if they have two copies of the variant, The New York Times reported. York Times.

Some experts worry that the emphasis on anti-amyloid drugs may discourage patients from participating in trials for treatments that might be better.

“For the field in general, I think it’s moving sideways and slowing progress,” Dr. Michael Greicius, a neurologist at Stanford University School of Medicine.

Dozens of other drugs are in clinical trials for Alzheimer’s, including drugs that attack important features like tau tangles and neuroinflammation, the Times reported.

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