Eli Lilly: to resubmit filing for rheumatoid arthritis drug.
(CercleFinance.com) - Eli Lilly will resubmit a new drug application for rheumatoid arthritis baricitinib to the US FDA before the end of January 2018, the company said on Wednesday.
Eli Lilly and partner Incyte said the resubmission package will include new safety and efficacy data after discussions with the US health regulator.
In April 2017, the FDA issued a complete response letter for baricitinib, denying approval of this treatment for moderate-to-severe rheumatoid arthritis (RA).
The resubmission will start a new six-month review cycle.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
Eli Lilly and partner Incyte said the resubmission package will include new safety and efficacy data after discussions with the US health regulator.
In April 2017, the FDA issued a complete response letter for baricitinib, denying approval of this treatment for moderate-to-severe rheumatoid arthritis (RA).
The resubmission will start a new six-month review cycle.
Copyright (c) 2017 CercleFinance.com. All rights reserved.