Baricitinib Approval Status
- FDA approved: No
- Generic name: baricitinib
- Company: Eli Lilly and Company and Incyte Corporation
- Treatment for: Rheumatoid Arthritis
Baricitinib is an oral selective JAK1 and JAK2 inhibitor in development for the treatment of rheumatoid arthritis.In April 2017, Eli Lilly and Company and Incyte Corporation announced the receipt of a complete response letter (CRL) from the FDA for the NDA of baricitinib for the treatment of rheumatoid arthritis. The CRL indicated that the FDA was unable to approve the application in its current form, and that additional clinical data would be needed to determine the most appropriate doses and to further characterize safety concerns across treatment arms.
Development Status and FDA Approval Process for baricitinib
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