Biopharmaceutical company Eli Lilly and Company (NYSE:LLY) and Incyte Corporation (NASDAQ:INCY) Friday jointly announced the receipt of approval from the US Food and Drug Administration (FDA) for the 2-mg dose of OLUMIANT (baricitinib) for the treatment of rheumatoid arthritis (RA), a chronic, painful and progressive form of arthritis.
The companies added that the OLUMIANT (baricitinib) is 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. OLUMIANT may be used as monotherapy or in combination with methotrexate (MTX) or other non-biologic DMARDs.
This US FDA approval of OLUMIANT is based on the partnership's Phase 3 clinical trial programme that demonstrated efficacy for difficult to treat patients with rheumatoid arthritis (RA). The clinical trial programme 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.
According to the company, 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).
In conjunction with the approval, the companies will conduct a randomized controlled clinical trial to evaluate the long-term safety of baricitinib in patients with rheumatoid arthritis.
Additionally, Lilly will launch OLUMIANT in the US by the end of Q2 2018 under its patient support programme, Olumiant Together. Incyte is now eligible to receive a USD100m milestone payment from Lilly following the approval of OLUMIANT.
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