How the FDA’s Delay of Baricitinib Impacts Eli Lilly and Incyte
Image Source: Paul Sableman The FDA dealt Eli Lilly and Incyte an unforeseen blow recently by rejecting their marketing application for Rheumatoid Arthritis candidate Baricitinib. Where does the duo go from here? By Alexander J. Poulos an Kris Rosemann The drug approval process is chock full of pitfalls, and until regulators give the final okay, anything can happen. The widely held consensus was Eli Lilly’s (LLY) and Incyte’s (INCY) marketing application for Rheumatoid Arthritis candidate Baricitinib would be approved, but the FDA shocked everyone by issuing a complete response letter requesting further data. Where does the duo of Eli Lilly and Incyte proceed from here? Baricitinib We were optimistic the FDA would approve Baricitinib for the indication of Rheumatoid Arthritis … Read more