Eli Lilly to Complete FDA Rolling Submission for Alzheimer's Drug Donanemab in Q1 2022

Compiled by | Li Tom

According to the latest news, Eli Lilly plans to complete the rolling regulatory submission in the first quarter of 2022, thereby gaining a favorable position in the next Alzheimer's disease treatment race. Eli Lilly has committed that its Alzheimer's candidate drug donanemab will achieve significant progress in 2022.

The company is actively catching up with Biogen, whose candidate drug Aduhelm received controversial accelerated approval this year. In June 2021, the U.S. FDA announced the accelerated approval of Biogen's monoclonal antibody drug aducanumab for marketing, used to treat Alzheimer's disease-induced mild cognitive impairment (MCI) and mild Alzheimer's disease.

Notably, this is the first new Alzheimer's disease treatment approved by the U.S. FDA since 2003, and also the first drug capable of halting disease progression. The U.S. FDA hopes that the approval of aducanumab will usher in a new era of treatment for neurodegenerative diseases. Some believe this approval will promote the development of drugs for brain diseases, while others think it will be a stain on the U.S. FDA, with such an irresponsible approval potentially bringing fatal side effects to Alzheimer's patients.

As the FDA’s regulatory window opens, Eli Lilly is also pushing full speed ahead with the regulatory progress of its drug donanemab. At a recent investor meeting, Eli Lilly stated that the rolling submission for donanemab will be completed "in the next few months," likely by the end of the first quarter of 2022. The company had previously also indicated that the submission for donanemab would be completed at some point next year.

In June this year, Eli Lilly and Company announced that donanemab had been granted Breakthrough Therapy Designation by the U.S. FDA. Donanemab is a monoclonal antibody that binds to the N3pG subtype of beta-amyloid. It can bind to beta-amyloid in amyloid plaques in the brains of Alzheimer's disease patients, thereby promoting the clearance of amyloid deposits in the patient's brain.

According to data from a Phase 2 clinical trial published in the New England Journal of Medicine in March this year, the monoclonal antibody Donanemab effectively clears β-amyloid (Aβ) and Tau amyloid protein deposits in patients' brains. In this Phase 2 clinical trial involving 257 patients with Alzheimer's disease, 131 received treatment with Donanemab, developed by Eli Lilly and Company, while the remaining 126 received a placebo over a treatment period of 72 weeks. Donanemab met the primary endpoint of the trial, slowing the decline in the integrated measure of cognition and daily function (iADRS) by 32% in patients with early Alzheimer’s disease.

In addition, the outside world is also paying attention to the head-to-head study results of donanemab against Aduhelm. The initial data of this study will begin to be released in the second half of 2022. In the investor update, Eli Lilly and Company stated that it would advance the pivotal trial of a next-generation amyloid-lowering antibody called N3PG-IV in 2022.

Reference Source: Lilly to kick off 2022 with completion of much anticipated FDA filing for Alzheimer's candidate