Eli Lilly said results from a Phase 3 trial of its investigational Alzheimer’s treatment donanemab showed that it significantly slowed cognitive and functional decline in people in the early stages of the disease. Lilly has already submitted the drug for Food and Drug Administration approval.
• If approved, donanemab can provide “clinically meaningful benefits” for Alzheimer’s patients, with the potential for completing their treatment in as soon as six months, said Lilly Neuroscience President Anne White. It would be the second drug that can slow the disease.
• The FDA gave Biogen full approval earlier this month for its Alzheimer’s drug Leqembi, which it makes with Japan’s Eisai. Safety issues for Alzheimer’s treatments remain. Lilly said in May that three trial participants died after developing brain swelling or bleeding issues from its Alzheimer’s treatment.
• In other pharmaceutical news, BridgeBio Pharma shares jumped 76% after positive results from its Phase 3 study of an investigational heart disease drug. It plans to submit a new drug application to the FDA before the end of this year.
• The FDA approved Sanofi and AstraZeneca’s drug to protect infants against respiratory syncytial virus, a rare but potentially deadly respiratory virus. Although not a vaccine, the drug named Beyfortis gives infants antibodies to neutralize the virus.
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