Eli Lilly's Olumiant has picked up its first regulatory approval with a nod from the European Commission to treat moderate-to-severe active rheumatoid arthritis.
The decision allows the drug's use either as a monotherapy or in combination with methotrexate to treat adult patients with the condition who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs).
It also gives Olumiant (baricitinib) the coveted position of becoming the first JAK inhibitor approved to treat rheumatoid arthritis in the European Union.
Lilly says approval was based on clinical studies in which the drug 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," noted Anthony Ware, senior vice president for product development and interim president, Lilly Bio-Medicines.
"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."
The approval triggers a $65-million milestone to Incyte, as written into the firms' 2009 exclusive worldwide license and collaboration agreement to develop and commercialise baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
"The European Commission's approval of baricitinib is an exciting milestone for the RA community in the EU," noted Steven Stein, Incyte's chief medical officer. "We're confident that baricitinib will help to meet the needs of healthcare providers and their patients as they work toward achieving long-term treatment goals."
US regulators are also currently reviewing the drug.