15. Olumiant

(Eli Lilly)

Active ingredient: baricitinib 
Disease: rheumatoid arthritis 
Sales estimate: $1.8 billion by 2022 
Approved: May 31 
Companies: Eli Lilly, Incyte 

The scoop: To say that Eli Lilly and Incyte’s baricitinib had a bumpy road would be an understatement. It was once expected to be one of 2017’s top drug launches but faced an FDA rejection in April that year, which pushed its approval into the next year. Ahead of Olumiant’s approval in May, an FDA panel voted overwhelmingly in favor of both dose levels’ efficacy but only supported the approval of the lower dose due to safety concerns, including pulmonary embolism and deep vein thrombosis. Olumiant eventually nabbed the nod it needed to take on Pfizer’s Xeljanz, the only other drug in its class approved for rheumatoid arthritis, but with caveats. Only the lower, less effective dose was approved, and even that came with a black-box safety warning of serious infections, malignancy and thrombosis risks. Analysts have predicted Olumiant to pull in $1.8 billion in sales by 2022, but that was before its complete response letter and safety concerns. — Amirah Al Idrus

15. Olumiant

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