Olumiant regulatory update

FDA issued a complete response letter to an NDA from Lilly and Incyte for Olumiant baricitinib to treat moderate to severe rheumatoid arthritis. The companies said FDA will require additional data to determine appropriate dosing for Olumiant and “further characterize safety concerns across treatment arms.” The partners declined to provide details, but said they will base the timing of a resubmission on further discussions with the agency. The European Commission approved the Janus kinase-1 (JAK-1) and JAK-2 inhibitor in February to treat moderate to severe active RA in adults who have not responded adequately to, or are intolerant of, disease-modifying anti-rheumatic drugs (DMARDs) (see BioCentury, Feb. 16)...