Olumiant FDA Approval History

Last updated by Judith Stewart, BPharm on June 14, 2022.

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, COVID-19, Alopecia

Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, COVID-19, and alopecia areata.

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 blockers.
- the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
- the treatment of adult patients with severe alopecia areata.
Olumiant is administered orally, once daily. In COVID-19, the course of treatment is administered for up to 14 days.
The Olumiant product label carries a Boxed Warning for the increased risk of serious infections, higher rate of all-cause mortality, higher rate of malignancies, higher rate of major adverse cardiovascular events (MACE), and thrombosis.
Warnings and precautions include gastrointestinal perforations, laboratory abnormalities, and serious hypersensitivity reactions. Common adverse reactions include upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.

Development timeline for Olumiant

Date	Article
Jun 13, 2022	Approval FDA Approves Lilly and Incyte's Olumiant (baricitinib) as First and Only Systemic Medicine for Adults with Severe Alopecia Areata
May 11, 2022	Approval FDA Approves Olumiant (baricitinib) Treatment for COVID-19 in Certain Hospitalized Adults
Jul 29, 2021	FDA Broadens Existing Emergency Use of Lilly and Incyte's Baricitinib in Patients Hospitalized with COVID-19 Requiring Oxygen
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	Approval 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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA