Alzheimer’s Drug Safety Hinges on Doctors Heeding FDA Warning

How safe Eisai Co. and Biogen Inc.’s Alzheimer’s drug is for patients will depend on whether physicians adequately heed the FDA’s warnings of potential brain swelling and bleeding, clinicians and researchers say.

The Food and Drug Administration granted on July 6 full traditional approval of Leqembi for the treatment of mild cognitive impairment or early dementia caused by Alzheimer’s disease. Traditional approval indicates late-stage studies confirmed the drug’s clinical benefit to slow progression of the disease. Alzheimer’s patients and their caretakers see it as a pivotal milestone in the research and treatment of the memory-loss disease.

The drug’s approved ...