Eli Lilly and Company (LLY) said, based on top-line efficacy results from two pivotal phase 3 trials (SLE-BRAVE-I and II), the company has decided to discontinue the phase 3 development program for OLUMIANT in lupus. The company is working with investigators to appropriately conclude the phase 3 SLE long-term extension trial, SLE-BRAVE-X.
Lilly noted that it is in ongoing discussion with the FDA regarding the status of the sNDA for OLUMIANT for the treatment of adults with moderate-to-severe atopic dermatitis. Given the Agency's position, there is a possibility that this could lead to a Complete Response Letter, the company said.
"We look forward to potential regulatory approvals for OLUMIANT in 2022, including COVID-19 for certain hospitalized patients in the U.S. and severe alopecia areata in the U.S., European Union and Japan, where OLUMIANT has the potential to be a first-in-disease treatment," said Lotus Mallbris, vice president of global immunology development and medical affairs at Lilly.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.