Lilly-Incyte Rheumatoid Arthritis Drug Is Rejected by U.S. FDA

Eli Lilly & Co. and Incyte Corp.’s experimental rheumatoid arthritis drug was rejected by U.S. regulators, who said more information was needed on baricitinib’s safety and effectiveness before it is widely used by Americans.

The U.S. Food and Drug Administration asked for additional evidence about the best dose for treating patients with moderate-to-severe disease, the companies said April 14 in a statement. The regulator also wants more data on potential safety concerns seen at different dose levels.

The decision is a blow for a drug that analysts had projected would generate more than $1 billion in annual sales by 2020, ...