Posted by Michael Wonder on 26 Oct 2021
Lilly pipeline success strengthens future growth potential
27 October 2021 - Lilly announces today its U.S. submission of tirzepatide in type 2 diabetes using a priority review voucher and initiation of a rolling submission for donanemab to the FDA for accelerated approval in early Alzheimer's disease.
The company submitted a new drug application to the U.S. FDA and a marketing authorisation application to the EMA for tirzepatide for the treatment of adults with type 2 diabetes.
A priority review voucher was applied to the new drug application, leading to an anticipated review time of eight months from the date of submission according to current FDA priority review timelines.
The company initiated rolling submission for donanemab to the FDA for accelerated approval in early Alzheimer's disease.
