By Colin Kellaher

 

Eli Lilly & Co. on Friday reported a pair of setbacks in their efforts to expand Olumiant, its arthritis drug co-developed with Incyte Corp., into other indications.

Eli Lilly said it is ending the Phase 3 development program for Olumiant in the autoimmune disease lupus based on top-line efficacy results from two pivotal studies.

The company said only one of the studies met its primary endpoint, while both missed key secondary endpoints.

Meanwhile, Eli Lilly said it is in ongoing talks with the U.S. Food and Drug Administration on the application seeking expanded approval of Olumiant for adults with moderate-to-severe atopic dermatitis, the most common form of the inflammatory skin disease eczema.

Eli Lilly said it currently doesn't have alignment with the FDA on the indicated population, and that there is a possibility that the agency could turn away the application.

Indianapolis-based Eli Lilly signed an exclusive world-wide license and collaboration agreement with Incyte, a Wilmington, Del., biopharmaceutical company, in late 2009 to develop and commercialize Olumiant and other compounds for inflammatory and autoimmune diseases.

 

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

 

(END) Dow Jones Newswires

January 28, 2022 08:46 ET (13:46 GMT)

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