FDA approves only lower dose of Eli Lilly, Incyte's Olumiant for rheumatoid arthritis

The FDA on Friday disclosed the approval of Eli Lilly and Incyte's Olumiant (baricitinib) at a 2-mg dose for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to TNF inhibitors. The agency however, following the lead from an advisory committee vote in April, declined to clear the higher 4-mg dose of the JAK inhibitor.  

The FDA noted that the approval was backed by safety and efficacy data from the OLUMIANT clinical trial programme, which included four Phase III trials. In the RA-BEAM study, Olumiant displayed superiority over placebo regarding signs and symptoms of moderate-to-severe rheumatoid arthritis after 12 weeks of treatment. The companies indicated that in the RA-BEACON trial, which included 527 patients who had an inadequate response or intolerance to one or more TNF inhibitors, results showed that after 12 weeks, patients administered Olumiant had significantly higher rates of ACR20 response compared to patients in the placebo group (49 percent versus 27 percent respectively).  

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Lilly Bio-Medicines president Christi Shaw remarked "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." However, Shaw said "we were disappointed, maybe not surprised, but disappointed, that it (label) didn't allow for the ability to use it earlier in therapy."

Commenting on the news, Morgan Stanley analyst David Risinger said "the Olumiant approval was a bit worse than the panel's recommendation," noting that the vote in favour was for patients who were resistant to methotrexate. Meanwhile, J.P. Morgan analyst Chris Scott remarked "while an Olumiant 2 mg-dose approval gives Lilly a path to market...we see a relatively limited US commercial opportunity at the lower dose." Scott estimates US revenue for the therapy to be of approximately $400 million by 2022.

Eli Lilly is expected to launch Olumiant by the end of the second quarter at an annual price of around $25 000, which Shaw noted is 60 percent less than AbbVie's TNF inhibitor Humira (adalimumab) and half of Pfizer's JAK inhibitor Xeljianz (tofacitinib). The FDA required Olumiant's label to carry a boxed warning including risk of thrombosis, serious infections and malignancies including lymphoma.


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