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Eli Lilly's Alzheimer's disease drug donanemab will complete FDA rolling submission in 2022

 Last Update: 2021-12-27
 Source: Internet
 Author: User

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CompilationTom Lee

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 competition

The company is actively catching up with Biogen, and the company's drug candidate Aduhelm received a controversial accelerated approval this year

It is worth noting that this is the first new drug for Alzheimer's disease approved by the US FDA since 2003, and it is also the first drug that can prevent the progression of the disease

With the opening of the US FDA regulatory window, Eli Lilly is also advancing the regulatory progress of its donanemab at full speed

In June of this year, Eli Lilly announced that donanemab has been granted breakthrough therapy designation by the US FDA

According to data from a Phase 2 clinical trial published in the New England Journal of Medicine in March this year, Donanemab monoclonal antibody can effectively remove β-amyloid (Aβ) and Tau amyloid deposits in the brain of patients

In addition, the outside world is also paying attention to the results of a donanemab head-to-head study on Aduhelm.

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

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