Lilly lays out faster time frame for FDA drug resubmission
Aug. 30, 2017
INDIANAPOLIS (AP) — Eli Lilly says it will resubmit its potential rheumatoid arthritis treatment to regulators several months faster than expected.
The drugmaker said Wednesday that it will give baricitinib back to the Food and Drug Administration for review by the end of January, and the agency will not require a new clinical study.
Lilly had said in late July that the resubmission could take at least 18 months, and regulators indicated they wanted new research. The Indianapolis drugmaker came up with a new time frame after recent talks with the federal agency.
Eli Lilly and Co. bought the potential drug from Incyte in 2009 and is leading the push to get it approved.
Rheumatoid arthritis is a chronic inflammatory disease that affects the joints and destroys soft tissue, cartilage and bone.