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, Aduhelm, despite warnings from the agency's independent advisers that it hasn't been shown to help slow the brain-destroying disease. It's the first new Alzheimer’s drug in nearly 20 years and the only therapy that US 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 help clear a protein called beta-amyloid from the brain.
Lilly said 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. 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.
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