The agency determined that the potential of slowing the devastating disease in patients with mild cognitive impairment outweigh the risks of brain bleeds.
The Food and Drug Administration on Tuesday granted approval to a closely watched Alzheimer’s drug, concluding that the benefits of modestly slowing progression of the devastating disease outweigh its risks, drugmaker Eli Lilly announced.
Kisunla, which is the brand name for donanemab, slowed the cognitive and functional decline of patients with mild cognitive impairment by 35 percent over 18 months, a. The drug works by clearing a sticky plaque in the brain called amyloid beta, which is associated with the disease. Still, like the anti-amyloid drugs that came before it, donanemab has not been free of controversy. Three patients who received the drug in a clinical trial died of a complication from the drug. The condition, called ARIA, can cause the brain to swell or bleed. No such deaths occurred in the placebo group. Critics have also said that donanemab’s benefits, while statistically significant, are.
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