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Today the US Food and Drug Administration approved baricitinib (Oluminant) at the lower dose of 2 mg per day for use in adults with with moderate-to-severe active rheumatoid arthritis (RA) who have had an inadequate response to commonly-used treatments known as TNF inhibitors.
This follows the Arthritis Advisory Committee meeting of April 23rd, wherein the committee only recommended the lower 2mg dose (not the proposed 4 mg dose) and expressed concerns about some safety signals, especially with regard to venous thromboembolic events (VTE).
Currently Oluminant is approved in over 40 countries at both the 2 mg and 4 mg doses.
Another potential limitation is ithe indication for use in only TNF refractory RA patients..
The drug's label here carries a boxed warning, the strictest form of an FDA warning, and warns of serious infections, malignancies including lymphoma and risk of blood clotting.