Eli Lily's rheumatoid arthritis drug baricitinib got Europe's okay.
The European Commission has given Lilly and Incyte permission to market baricitinib (Olumiant) for treatment of moderate-to-severe rheumatoid arthritis for patients who can't take other disease-modifying drugs or for whom those drugs do not work.
According to Lilly, its product is the first JAK inhibitor approved for RA and has "demonstrated significant improvement in the signs and symptoms of RA compared to standard of care therapies." Those include adalimumab (Humira/AbbVie) the company said in a news release.
The approval came ofter four completed clinical studies in adults with RA. Two of those studies included patients being treated with methotrexate or adalimumab. The JAK enzyme is a cytokine implicated in the pathogenesis of many inflammataory and autoimmune disease.
Lilly researchers believe that by inhibiting JAK their drug may be useful for other inflammatory conditions as well as RA. The drug is taken in 4 mg or 2 mg tablets. It may be used as a monotherapy or with methotrexate.
There are more than 23 million people worldwide who have RA, and it affects three times more women. Current treatment includes NSAIDs, synthetic disease-modifiying anti-rheumatics, and injectable biological disease-modifying antirheumatic drugs.
Despite all these treatment options, many patients relapse or do not meet their treatment goals.
Baricitinib is currently being evaluated in the US and Japan and is in phase 2 trials for atopic dermatitis and lupus. A phase 3 trial for psoriatic arthritis is due to start later this year.