Regulatory Affairs

Lilly and Incyte gain FDA approval for lower dose of RA drug Olumiant

Published 04 June 2018

The US Food and Drug Administration (FDA) has approved a lower dose of Olumiant (baricitinib), a daily once oral Janus kinase (JAK) inhibitor developed by Lilly and Incyte to treat moderately-to-severely active rheumatoid arthritis (RA).

The approval is for a 2mg dose of the drug in adult patients who did not show adequate response to one or more tumor necrosis factor (TNF) inhibitor therapies.

Olumiant has been indicated to be used as monotherapy or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs).

However, the drug is not recommended to be used in combination with other JAK inhibitors or biologic DMARDs, or with potent immunosuppressants like azathioprine and cyclosporine.

Olumiant’s approval was driven by the findings of a phase 3 clinical trial program that showed efficacy of the JAK inhibitor for difficult to treat RA patients.

Included in the program is the RA-BEACON study featuring 527 patients, who were randomly grouped to be subjected to Olumiant 2mg, baricitinib 4mg or placebo, along with conventional DMARDs that they were currently using.

Lilly Bio-Medicines president Christi Shaw said: “RA patients continue to experience unique challenges accessing the treatments prescribed by their healthcare providers.

“Therefore, we are determined to continue our work with stakeholders to demonstrate value across the healthcare system so providers have greater choice in prescribing treatments to fit individual patient needs.”

Lilly said that it plans to launch Olumiant in the US by the end of the second quarter of this year.

Following the FDA approval, Incyte, which had licensed the RA drug to Lilly, will be eligible to get a milestone payment of $100m from the latter.

In February 2017, Olumiant 4mg and 2mg tablets were granted marketing authorization in Europe for the treatment of moderate-to-severe active RA in adults who have inadequate response to, or who are intolerant to, one or more DMARDs.

The approval in Europe was followed by an approval in June from Japan's Ministry of Health, Labor and Welfare for the two doses of the drug for the same indication.


Image: Eli Lilly and Company's global headquarters, in Indianapolis, Indiana. Photo: courtesy of Guanaco152003/