LLY Eli Lilly and Co

   By Colin Kellaher 
 

Eli Lilly & Co. (LLY) and Incyte Corp. (INCY) on Friday said the Food and Drug Administration approved the two-milligram dose of their rheumatoid-arthritis treatment baricitinib.

The lower-dose version of baricitinib, to be marketed under the name Olumiant, was approved as a once-daily oral medication for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor-necrosis-factor inhibitor therapies, the companies said.

An FDA advisory panel in April recommended the agency approve the two-milligram dose of the drug but recommended against approval of a four-milligram dose, citing safety concerns, including the risk of certain types of blood clots. The companies on Friday said Olumiant will carry a safety warning for the risk of serious infections, malignancies and thrombosis.

Indianapolis-based Eli Lilly said that it plans to launch Olumiant in the U.S. by the end of the second quarter and that the price will be 60% less than the leading TNF inhibitor.

The FDA approval triggers a $100 million milestone payment to Incyte from Lilly, which the Wilmington, Del., biopharmaceutical company said it will recognize in the second quarter.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

June 01, 2018 13:09 ET (17:09 GMT)

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