Lilly to get FDA approval for potential Alzheimer's drug

Eli Lilly is almost prepared 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 meals and Drug Administration later this year.

The announcement comes a few weeks following the FDA approved a treatment from rival Biogen, despite warnings from the agency’s independent advisers that it hasn’t been displayed to greatly 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 practically twenty years and the only therapy that U.S. regulators have said can likely alter the course of the disease, instead of 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 mind.

Lilly said Thursday that it will seek approval for donanemab predicated on results from a mid-stage clinical study of the drug involving 272 patients with an early form of the disease. Researchers said donanemab showed signs of slowing a decline in cognition and daily function for patients who took it compared to those that took a placebo or fake drug.

The FDA gave donanemab a “breakthrough therapy” designation, which is intended to speed the development and overview of drugs that show signs to be a noticable difference over established treatments.

Lilly might be able to file its application for approval within the next two or three months because the drugmaker appears to have all the data it requires, said Dr. Vamil Divan, an analyst who covers the business for Mizhuho Securities USA.

The Indianapolis company also will examine the drug in a more substantial, late-stage study. A spokeswoman said Lilly plans to complete enrollment for the reason that study by the finish of the entire year, and an 18-month treatment period will observe.

Biogen said Wednesday that another experimental Alzheimer’s treatment it developed with Japan’s Eisai Co. also received a breakthrough remedy designation from the FDA. Researchers are examining that drug, lecanemab, in a late-stage study.

The companies gave virtually no time frame for if they might seek regulatory approval.

Some 6 million persons in the U.S. and more worldwide have Alzheimer’s disease, which steadily attacks areas of the mind needed for memory, reasoning, communication and basic daily tasks.

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

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

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

Eli Lilly and Co. shares jumped almost $17, or almost 8%, to $233.97 Thursday afternoon as the Standard & Poor's 500 index climbed less than 1%.

Shares of Biogen fell more than 5%, or $20.29, to $351.61.