Olumiant Approval History
Reviewed on Jun 5, 2018 by J.Stewart B.Pharm
FDA Approved: Yes (First approved May 31, 2018)
Brand name: Olumiant
Generic name: baricitinib
Dosage form: Tablets
Company: Eli Lilly and Company
Treatment for: Rheumatoid Arthritis
Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis.
Indications and Usage
Olumiant is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
Dosage and Administration
The recommended dose of Olumiant is 2 mg once daily, and may be used as monotherapy or in combination with methotrexate or other DMARDs.
Warnings and Precautions
Olumiant is approved with a Boxed Warning for the risk of serious infections, malignancies and thrombosis.
Common adverse reactions (greater than or equal to 1%) include: upper
respiratory tract infections, nausea, herpes simplex, and herpes zoster.
Development History and FDA Approval Process for Olumiant
|Jun 1, 2018|| FDA Approves Olumiant (baricitinib) 2 mg Tablets for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis|
|Apr 23, 2018||FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis|
|Aug 30, 2017||Lilly to File Baricitinib Resubmission to U.S. FDA Before End of January 2018|
|Jul 25, 2017||Lilly and Incyte Provide Update on Baricitinib|
|Apr 14, 2017||FDA Issues Complete Response Letter for Baricitinib|
|Jan 13, 2017||U.S. FDA Extends Review Period For Baricitinib, An Investigational Rheumatoid Arthritis Treatment|
|Nov 14, 2016||New Analyses Of Phase 3 Trials Show Improvements In Rheumatoid Arthritis Symptoms Following Treatment With Baricitinib Across Diverse Population Of Patients|
|Mar 31, 2016||Phase 3 Study Findings Demonstrate Treatment With Baricitinib Results In Significant Improvements For Patients With Rheumatoid Arthritis Who Had Inadequate Response To Biologics|
|Jan 19, 2016||Lilly and Incyte Announce Submission of NDA to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis|
|Oct 14, 2015||Baricitinib Demonstrates Superiority To Adalimumab In Improving Signs And Symptoms Of Rheumatoid Arthritis In Pivotal Phase 3 Study|
|Sep 29, 2015||Baricitinib Superior To Methotrexate In Reducing Signs And Symptoms In Pivotal Phase 3 Study In Patients With Rheumatoid Arthritis|
|Jun 10, 2015||Lilly and Incyte Unveil Detailed Data on Two Pivotal Studies of Baricitinib in Rheumatoid Arthritis|
|Feb 23, 2015||Baricitinib Superior to Placebo in Reducing Rheumatoid Arthritis Disease Activity in Second Phase 3 Study|
|Dec 9, 2014||Lilly And Incyte Announce Positive Top-Line Results From Phase 3 Trial Of Baricitinib In Moderate To Severe Rheumatoid Arthritis|
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