Eli Lilly: FDA extends review of baricitinib
(CercleFinance.com) - Eli Lilly and Incyte have announced that the US Food and Drug Administration (FDA) has extended the review period for the supplemental new drug application (sNDA) for baricitinib, as a treatment for moderate-to-severe atopic dermatitis.
The FDA wants to take time to analyse additional data submitted by Eli Lilly in response to recent FDA requests for information.
The group says that it remains confident in baricitinib and believe it has the potential to be an effective new treatment option for these patients.
The additional delay does not affect the group's previously published financial guidance for 2021, it said.
Copyright (c) 2021 CercleFinance.com. All rights reserved.
The FDA wants to take time to analyse additional data submitted by Eli Lilly in response to recent FDA requests for information.
The group says that it remains confident in baricitinib and believe it has the potential to be an effective new treatment option for these patients.
The additional delay does not affect the group's previously published financial guidance for 2021, it said.
Copyright (c) 2021 CercleFinance.com. All rights reserved.