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

horse race
Expected in the new year for donanemab is a limited—but intriguing—head-to-head study against Aduhelm. (Pixabay)

Eli Lilly is upping the ante in the race for the next Alzheimer’s disease treatment by scheduling the completion of a rolling regulatory submission for the first quarter of 2022.

The Indianapolis-based Big Pharma has promised a big year in 2022 for its Alzheimer’s candidate donanemab. The company is chasing Biogen, which snagged a controversial accelerated approval for Aduhelm in June. With the regulatory window cracked open, Lilly is going full speed ahead.

Lilly, which is hosting an investor meeting today, said the rolling submission will be completed “in the coming months” and likely by the end of the first quarter of 2022. The company had previously said the filing would be completed sometime next year.

Expected in the new year for donanemab is a limited—but intriguing—head-to-head study against Aduhelm. Initial data from that study will begin to roll out in the second half of 2022. 

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Also in the investor update was a note that Lilly will move a next-generation amyloid-lowering antibody called N3PG-IV into pivotal trials in 2022. The company will showcase some phase 1 data on the candidate at the event being held today.