As expected, US regulators have approved the lower dose of Eli Lilly/Incyte’s once-daily JAK inhibitor Olumiant as treatment for rheumatoid arthritis (RA).
The decision comes after the US Food and Drug Administration’s Arthritis Advisory Committee recommended early this year that the 2mg dose of the drug be approved for moderately-to-severely active RA in adults who have had an inadequate response or are intolerant to methotrexate.
While the Advisory Committee unanimously supported the efficacy of the 4mg dose of Olumiant (baricitinib), it did not recommend its approval based on the adequacy of the safety and benefit-risk profiles, Lilly said at the time.
The submission underpinning approval of the 2mg dose included data from the RA-BEACON study, which involved 527 patients who had an inadequate response or intolerance to one or more TNF inhibitor therapies.
The data showed that patients treated with Olumiant had significantly higher rates of ACR20 response versus placebo-treated patients at Week 12 (49 percent versus of 27 percent, respectively).
“Despite the advancements we’ve seen in the RA treatment landscape over the past several decades, many patients are still failing to achieve their disease management goals,” said Seth Ginsberg, co-founder and president of CreakyJoints and the Global Healthy Living Foundation.
“As it’s important for RA patients to have multiple treatment options available to best suit their disease characteristics and experiences, the approval of Olumiant is very encouraging for our community.”
The drug’s label carries a boxed warning for the risk of serious infections, malignancies and thrombosis, but the most common adverse events included upper respiratory tract infections, nausea, herpes simplex and herpes zoster.
Lilly said it would launch the drug in the US by the end of the second quarter of this year.
Olumiant was approved for use within the European Union early last year.