Eli Lilly and Incyte have secured US regulatory approval for the use of olumiant to treat adults with moderate-to-severe active rheumatoid arthritis (RA).
The US Food and Drug Administration (FDA) authorised the 2mg dose of the drug for once-daily use in patients who experienced an inadequate response to one or more tumour necrosis factor (TNF) inhibitor therapies.
However, the drug did not gain approval for use in combination with Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (bDMARDs) or potent immunosuppressants.
Olumiant is also a JAK inhibitor with more success against JAK1, JAK2 and TYK2 enzymes than JAK3. It has been approved in more than 40 markets.
Eli Lilly Bio-Medicines president Christi Shaw said: “We are pleased to provide RA patients in the US an effective treatment option with olumiant as people with RA who have had an inadequate response to TNF inhibitors are generally considered to be some of the most difficult to treat RA patients.”
The FDA decision is based on data from the randomised, double-blind, placebo-controlled Phase III RA-BEACON trial conducted with 527 subjects. The study showed 2mg olumiant led to significantly higher ACR20 response rates and early symptom relief.
The regulatory agency granted the approval with a warning for the risk of malignancies, thrombosis and serious infections that can result in hospitalisation or death.
In addition, the FDA asked the companies to validate the long-term safety of baricitinib in a randomised controlled trial for rheumatoid arthritis.
Eli Lilly plans to commercially launch olumiant in the US by the end of the second quarter of this year. It will be priced 60% lower than the leading TNF inhibitor.