By TOM MURPHY
INDIANAPOLIS (AP) — 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. Researchers said donanemab showed signs of slowing a decline in cognition and daily function for patients who took it compared to those who took a placebo or fake drug.
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.
Biogen said Wednesday that another experimental Alzheimer’s treatment it developed with Japan’s Eisai Co. also received a breakthrough therapy designation from the FDA. Researchers are examining that drug, lecanemab, in a late-stage study.
The companies gave no time frame for when they might seek regulatory approval.
Some 6 million people in the U.S. and many more worldwide have Alzheimer’s disease, 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 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 $15.87, or 7.3%, to close Thursday at $232.97, while the Standard & Poor’s 500 index climbed less than 1%.
Shares of Biogen fell 6.1%, or $22.74, to end the day at $349.16.
Follow Tom Murphy on Twitter: @thpmurphy
Source: Orange County Register