Eli Lilly Reports Olumiant Setbacks in Lupus, Atopic Dermatitis
January 28 2022 - 9:01AM
Dow Jones News
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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