Eli Lilly and Co said on Thursday it will apply for U.S. health regulator’s accelerated approval this year for its experimental Alzheimer’s drug, weeks after Biogen Inc’s controversial drug for the disease was approved.
Lilly’s shares jumped over 8 per cent, while Biogen fell nearly 5 per cent. Biogen’s aduhelm was approved under the U.S. Food and Drug Administration’s accelerated approval pathway, for which the agency came under intense criticism as questions were raised on the strength of the clinical data.
Like aduhelm, Lilly’s dug candidate, donanemab, too is designed to remove clumps of a protein called beta amyloid from the brain. The protein is believed to be a contributing cause of Alzheimer’s.
“Following the approval of Biogen’s Aduhelm earlier this month based in large part on its ability to lower amyloid plaque, we have been assuming this (accelerated approval) might be a possible path for Lilly to take,” Mizuho analyst Vamil Divan said in a client note.
Lilly in January said early results from a midstage trial of 272 patients showed donanemab met its main goal of slowing the rate of decline in cognition and function in patients at an early stage of the mind-wasting disease.
Results for the trial’s secondary goals measuring cognition and function were positive, but not all of them reached statistical significance.
Lilly is continuing to study the drug in a late-stage study.
The company said it would file a marketing application for donanemab based on data from the midstage trial.
“Lilly plans to submit the application this year but, given that Lilly appears to already have all the data they need to file, we assume they may be able to submit the filing in 2-3 months,” Divan said.
The FDA on Thursday granted donanemab a breakthrough therapy designation, meant to expedite the development and review of medicines for serious or life-threatening conditions.
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