Lilly to seek FDA approval for potential Alzheimer's drug donanemab

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.

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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 data from a mid-stage clinical study of the drug involving 272 patients. The FDA gave donanemab a "breakthrough therapy" designation, which is intended to speed the development and review of drugs that show signs of being an improvement over established treatments.

Lilly may be able to file its application for approval in the next two or three months since the drugmaker appears to have all the data it needs, said Dr. Vamil Divan, an analyst who covers the company for Mizhuho Securities USA.

The Indianapolis company also will examine the drug in a larger, late-stage study. A spokeswoman said Lilly plans to complete enrollment in that study by the end of the year, and an 18-month treatment period will follow.

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Some 6 million people in the U.S. and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and basic daily tasks.

Lilly and several other drugmakers have previously failed in attempts to find a treatment that slows the progression of the mind-robbing disease.

More than four years ago, Lilly said another potential drug it developed called solanezumab did not work better than a placebo treatment in a study of over 2,100 people.

That drug also aimed to clear potentially harmful protein from the brain.

The price of Eli Lilly and Co. shares jumped nearly $19, or almost 9%, to $236.02 in late-morning trading while broader indexes rose less than 1%.

That topped an all-time high of $235.85 that the stock reached earlier this month, according to FactSet.