Damien Garde and Adam Feuerstein report for Stat News on likely FDA approval of a new drug to treat Alzheimer’s disease. In a clinical trial, the drug was shown to slow cognitive decline by 27 percent. Biogen and Eisai developed the drug, which they call lecanemab.
Earlier this year, Biogen tried unsuccessfully to get FDA approval of Aduhelm to treat Alzheimer’s disease. But, Aduhelm showed limited at best clinical benefits and serious side effects.
The clinical trial for lecanemab involved 1,800 patients with early-stage Alzheimer’s disease. It showed that patients fared better in terms of memory loss than patients who did not receive the drug. It also showed toxic plaque (amyloid) reduction in the brain and other benefits in terms of preserving memory and brain function.
One in five patients who received lecanemab had brain swelling or bleeding. But fewer than three in one hundred showed symptoms.
The FDA has said it will decide whether to conditionally approve lecanemab by Jan. 6. With new data, it could give full approval to lecanemab by the summer.
The trial showed that patients who received lecanemab performed .45 points better on memory, problem-solving and personal care than patients who received the placebo, out of a total score of 18. The .45 point improvement is considered statistically significant, but this improvement may not be noticeable in a patient. Some experts believe the data available shows minimally significant positive results and want more data.
Patients receive lecanemab twice a month through infusion.
Here’s more from Just Care:
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