Baricitinib Approved in the EU for Use in Rheumatoid Arthritis Save

The European Commission has approved Eli Lilly's rheumatoid arthritis (RA) drug Olumiant (baricitinib) for use in Europe.  It is indicated for RA patients with moderate-to-severe active disease, in adults who have not responded one or more disease-modifying antirheumatic drugs (DMARDs). It can be used as monotherapy or in combination with DMARDs.  

This is the first regulatory approval for a JAK inhibitor in the EU and is the first regulatory approval for baricitinib worldwide.

Baricitinib is a once-daily oral, selective and reversible JAK1 and JAK2 inhibitor. The drug will be available as 2 mg and 4 mg tablets.  It has proven its efficacy and safety in 5 key registraton trials - BEGIN (DMARD naive), BEACON (TNF-IR), BEAM (MTX-IR), BUILD ( DMARD-IR), and BEYOND (long term exposure study). 

The FDA is still reviewing baricitinib for approval in the US.