FDA grants AK1/2 inhibitor Olumiant (baricitinib) fast-track eligibility to treat systemic lupus erythematosus
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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, http://giant Eli Lilly and partner Incyte http://
announcedthat the u.SFood andDrug(http://Administration (
) of theFDA(http:// had granted JAK1/2 inhibitor, The Baricitinib, a fast-track access to treating systemic lupuscurrently, Lilly and Incyte are evaluating the efficacy and safety of two doses of Olumiant in phase III clinical studiesearlier this year, Lilly and Incyte published Phase II study data for Olumiant Therapeutic SLE in The Lancet, which supports the FDA's grantofing of the drug SLE fast-track eligibilityIn the study, 314 SLE patients were randomly given a placebo, 2mg Olumiant, and 4mg Olumiant at a 1:1:1 ratiodata showed that in the 24th week of treatment, the proportion of patients with SLE-4 remission in the 4mg Olumiant treatment group was significantly higher than in the placebo group (64.4% vs 47.6%, p 0.05) In addition, the proportion of patients with SLE-related arthritis or rash relief in the 4mg Olumiant treatment group was significantly higher during the 24-week treatment period than in the placebo group (67.3% vs 53.3%, p 0.05) However, there was no statistically significant difference between the 2mg Olumiant treatment group and the placebo group in terms of primary or secondary endpoints
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