Breaking news: The FDA on Thursday gave full approval, for the first time, to a drug that modestly slows Alzheimer’s disease — a development that offers a degree of hope but also raises difficult questions about safety, effectiveness and cost.
by 27 percent over 18 months compared with placebo. That represented a five-month slowdown in progression, experts said.
The FDA said it is requiring the drug’s label to include a “boxed warning.” That warning, sometimes called a “black box,” says that Leqembi, and other members of a new class of anti-amyloid drugs, can cause brain swelling and bleeding. The side effect, called ARIAamyloid-related imaging abnormalities — usually is asymptomatic. But life-threatening incidents can occur in rare cases, the warning says.
Elsewhere in the label, the FDA urges physicians to use caution in prescribing Leqembi to people on blood thinners. Some clinics have said they don’t plan to give the drug to people on blood thinners because of concerns about possible bleeding in the brain. Jerry Avorn, professor of medicine at Harvard Medical School, worries patients will wrongly expect the medication to improve their memory and thinking skills. “That’s untrue,” he said. “It will just make grandma forget a tiny bit less.” And he noted that patients who get the drug will have to undergo multiple brain scans and make frequent trips to infusion centers, which could be a burden.
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