Olumiant FDA Approval History
Reviewed by J.Stewart B.Pharm. Last updated on Jun 5, 2018.
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 Timeline for Olumiant
|Nov 19, 2020||Baricitinib and Remdesivir Combination Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19|
|Jun 15, 2020||Lilly Begins a Phase 3 Clinical Trial with Baricitinib for Hospitalized COVID-19 Patients|
|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|
|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|
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