FDA approves Olumiant to treat rheumatoid arthritis. - Eli Lilly.

Eli Lilly and Company and Incyte Corporation announced that the FDA has approved the 2-mg dose of Olumiant (baricitinib), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies. Use of Olumiant in combination with other Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (bDMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. Oluminat may be used as monotherapy or in combination with methotrexate (MTX) or other non-biologic DMARDs.

The Olumiant clinical trial program included the RA-BEACON study, a randomized, double-blind, placebo-controlled study in which patients were randomly assigned to receive Olumiant 2 mg, baricitinib 4 mg or placebo, in addition to conventional DMARDs that they were currently using. This study included 527 patients who had an inadequate response or intolerance to one or more TNF inhibitor therapies. Patients could have had prior therapy with other bDMARDs. The study results showed that significantly higher ACR20 response rates and improvement in all individual ACR20 component scores were observed at Week 12 with Olumiant. The study found that patients treated with Olumiant had significantly higher rates of ACR20 response versus placebo-treated patients at Week 12 (49% of Olumiant-treated patients versus 27% of placebo-treated patients). Olumiant also demonstrated early symptom relief, with ACR20 responses seen as early as Week 1. Patients treated with Olumiant reported significant improvements in physical function based on the Health Assessment Questionnaire Disability Index (HAQ-DI) (recording an average score of 1.71 before treatment and 1.31 at Week 12) compared to placebo-treated patients (who recorded an average score of 1.78 before treatment and 1.59 at Week 12).

Olumiant is approved with a Boxed Warning for the risk of serious infections, malignancies and thrombosis. Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving Olumiant. Lymphoma and other malignancies have been observed in patients treated with Olumiant as well. Additionally, thrombosis, including deep venous thrombosis, pulmonary embolism and arterial thrombosis, some fatal, have occurred in patients treated with Olumiant.

As part of the approval, the companies have agreed to conduct a randomized controlled clinical trial to evaluate the long-term safety of baricitinib in patients with rheumatoid arthritis.

Lilly will launch Olumiant in the U.S. by the end of the second quarter of 2018. The price of Olumiant will be 60% less than the leading TNF inhibitor. Lilly will be offering a patient support program, Olumiant Together.