, an orally administered Janus kinase (JAK) inhibitor, to treat adults with moderate to severe rheumatoid arthritis (RA) who have responded inadequately or poorly to methotrexate, its manufacturer, Eli Lilly, announced June 1. The regulators voted against approval of the 4-mg dose because of concerns about the safety profile.
Olumiant is accompanied by a boxed warning about the risk of serious infections, malignancies, and thrombosis. Patients taking Olumiant also have experienced tuberculosis and opportunistic viral, fungal, and bacterial infections. These infections have led to hospitalization or death.
As part of the approval, Lilly and the original developer of baricitinib, Incyte, have agreed to conduct further randomized and controlled clinical trials to evaluate the long-term safety of Olumiant.
Lilly said in itsthat it expects to launch Olumiant in the United States by the end of the second quarter of 2018 at a targeted price that is 60% less than “the leading TNF inhibitor.” Additionally, Lilly will offer patient support in the form of a patient support program called Olumiant Together. More information for the program can be obtained by calling 844-OLUMIANT.