Lilly to seek FDA approval for potential Alzheimer’s drug

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Eli Lilly is nearly ready to take another shot at getting approval for a possible Alzheimer’s drug.

The drugmaker said Thursday that it plans to submit its potential treatment donanemab to the Food and Drug Administration later this year.

The announcement comes a few weeks after the FDA approved a treatment from rival Biogen, despite warnings from the agency’s independent advisers that it hasn’t been shown to help slow the brain-destroying disease.

The agency approved Biogen’s Aduhelm based on study results showing it seemed “reasonably likely” to benefit Alzheimer’s patients. It’s the first new Alzheimer’s drug in nearly 20 years and the only therapy that U.S. regulators have said can likely alter the course of the disease, rather than temporarily ease symptoms like thinking problems, memory lapses and anxiety.

Both Aduhelm and Lilly’s potential treatment, donanemab, help clear a protein called beta-amyloid from the brain.

Lilly said Thursday that it will seek approval for donanemab based on results from a mid-stage clinical study of the drug involving 272 patients with an early form of the disease.

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