Eli Lilly Alzheimer’s Drug Gains FDA Breakthrough Status
- Drugmaker to submit application for approval later this year
- Lilly shares gain as drug joins similar therapies with status
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Eli Lilly & Co. rose after its experimental drug for Alzheimer’s gained breakthrough status from U.S. regulators, a designation that will speed its consideration for approval.
The Lilly drug now becomes the third to receive the designation based on its ability to attack amyloid, an abnormal protein believed to be involved in the damage Alzheimer’s causes in the brain. Lilly said on Thursday it intends to submit later this year a biologics license application for its therapy, called donanemab, under the accelerated approval pathway.