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 (RA) in light of the impressive data generated during recent clinical trials. We found the RA-BEAM study particularly compelling; the study collected head-to-head data comparing Baricitinib to Humira, the current standard of care, and the data appeared encouraging, at least initially.
The FDA initially asked for an additional three months to examine the data–an ominous sign in hindsight–but upon further review of the data, the FDA concluded additional clinical trials would be necessary to gather more clinical data to optimize dosage and characterize the safety profile of the treatment, a costly delay for the partnership of Incyte and Eli Lilly. We are surprised by the FDA’s stance in light of Baricitinib recently gaining marketing approval in Europe. While each regulatory body acts independently of each other, such a significant difference of opinion between the two is not common.