Johnson & Johnson unit seeks US FDA label expansion for RA drug Simponi

Centocor Ortho Biotech, a subsidiary of US health care major Johnson & Johnson (NYSE: JNJ), has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration seeking to expand the Simponi (golimumab) physician label to include inhibition of the progression of structural damage and maintenance of improvement in signs and symptoms and physical function in the treatment of patients with active psoriatic arthritis (PsA).

A once-monthly subcutaneous anti-TNF-alpha therapy with marketing authorizations in the USA, Europe and Canada, Simponi is approved for the treatment of moderately to severely active RA in combination with methotrexate, active PsA and active AS. The drug is marketed outside the USA by fellow US drug major Merck & Co, and is the subject of a dispute between the companies in that J&J argues that the merger of Merck and Schering-Plough triggered a change-of-control provision in the agreement allowing it to reclaim full rights to the drug, as well as its forerunner Remicade (infliximab).

Second sBLA filing this year