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Olumiant Approval History

Reviewed on Jun 5, 2018 by J.Stewart B.Pharm.

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.

Adverse Reactions
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

DateArticle
Jun  1, 2018Approval FDA Approves Olumiant (baricitinib) 2 mg Tablets for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis
Apr 23, 2018FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis
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
Nov 14, 2016New Analyses Of Phase 3 Trials Show Improvements In Rheumatoid Arthritis Symptoms Following Treatment With Baricitinib Across Diverse Population Of Patients
Mar 31, 2016Phase 3 Study Findings Demonstrate Treatment With Baricitinib Results In Significant Improvements For Patients With Rheumatoid Arthritis Who Had Inadequate Response To Biologics
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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