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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

Aug 30, 2017Lilly to File Baricitinib Resubmission to U.S. FDA Before End of January 2018
Jul 25, 2017Lilly and Incyte Provide Update on Baricitinib
Apr 14, 2017FDA Issues Complete Response Letter for Baricitinib
Jan 13, 2017U.S. FDA Extends Review Period For Baricitinib, An Investigational Rheumatoid Arthritis Treatment
Jan 19, 2016Lilly and Incyte Announce Submission of NDA to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis
Oct 14, 2015Baricitinib Demonstrates Superiority To Adalimumab In Improving Signs And Symptoms Of Rheumatoid Arthritis In Pivotal Phase 3 Study
Sep 29, 2015Baricitinib Superior To Methotrexate In Reducing Signs And Symptoms In Pivotal Phase 3 Study In Patients With Rheumatoid Arthritis
Jun 10, 2015Lilly and Incyte Unveil Detailed Data on Two Pivotal Studies of Baricitinib in Rheumatoid Arthritis
Feb 23, 2015Baricitinib Superior to Placebo in Reducing Rheumatoid Arthritis Disease Activity in Second Phase 3 Study
Dec  9, 2014Lilly And Incyte Announce Positive Top-Line Results From Phase 3 Trial Of Baricitinib In Moderate To Severe Rheumatoid Arthritis

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