The agency granted accelerated approval to Leqembi on Friday.The agency granted accelerated approval to Leqembi on Friday.
the FDA granted accelerated approval to a second Alzheimer’s disease drug in the past two years that trial data show offers modest benefits to patients.
With a $26,500 annual price tag and Medicare, for now, only willing to pay for the drug if patients are enrolled in a trial, uptake of the drug may be limited. There are no further planned trials for the drug.
The latest trial data also show that 14 percent of people who received the drug experienced side effects, including brain swelling and bleeding, compared to 11 percent who received a placebo. In a continuation of the trial in which participants could choose to receive the drug, called Leqembi, three deaths have been reported. Its manufacturers — Eisai and Biogen — say it’s not certain those deaths were caused by the drug.
In clinical trials, Leqembi, formerly known as lecanemab, slowed the progressive cognitive decline associated with Alzheimer’s. It also reduced proteins that accumulate on the brain associated with the disease.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones,” Billy Dunn, the director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.
