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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.

Adverse Reactions
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, 2020Baricitinib and Remdesivir Combination Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19
Jun 15, 2020Lilly Begins a Phase 3 Clinical Trial with Baricitinib for Hospitalized COVID-19 Patients
Jun  1, 2018ApprovalFDA 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
Jan 19, 2016Lilly and Incyte Announce Submission of NDA to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis

Further information

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