Olumiant gains first regulatory approval, in Europe

The European Commission has granted marketing authorization for Olumiant (baricitinib) 4mg and 2mg film-coated tablets in Europe for the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs).

The drug’s developers, US pharma major Eli Lilly (NYSE: LLY) and partner biotech firm Incyte (Nasdaq: INCY), say this is the first regulatory approval around the world for Olumiant - the first JAK inhibitor approved to treat RA in the European Union - which may be used as monotherapy or in combination with methotrexate. In clinical studies, Olumiant has demonstrated significant improvement in the signs and symptoms of RA compared to standard of care therapies such as methotrexate and Humira (adalimumab) with background methotrexate.

"Despite clinical advances in treatment, many people with RA continue to struggle with the debilitating effects of this disease, which can lead to long-term joint damage and disability," said Anthony Ware, senior vice president for product development and interim president, Lilly Bio-Medicines, adding: "We believe that as a next-generation therapy in the EU, Olumiant will advance RA treatment by helping patients with moderate-to-severe disease feel better quickly."