Johnson & Johnson is hoping to get a new indication for its human monoclonal antibody Simponi, the rights to which are being fought over with Merck & Co, from the regulator in the USA.
J&J's Centocor Ortho Biotech has submitted a supplemental Biologics License Application to the US Food and Drug Administration to expand the label on Simponi (golimumab) to include treatment for patients with active psoriatic arthritis (PsA). The filing is based on data from the GO-REVEAL study.
This submission represents the second sBLA submission for Simponi this year, as Centocor made a filing in September to include the inhibition of the progression of structural damage in the treatment of moderately to severely active rheumatoid arthritis on the label. In April 2009, it was approved by the FDA as the first once-monthly anti-tumor necrosis factor-alpha therapy for the treatment of adults with moderately to severely active RA, active PsA and active ankylosing spondylitis.
"This application seeks to expand the Simponi label to include inhibiting the progression of structural damage, a potentially devastating manifestation sometimes associated with active psoriatic arthritis," said Jerome Boscia, head of clinical R&D at Centocor. He added that the move "marks an important clinical milestone in the continued lifecycle development" of the drug.
J&J, which holds the rights to Simponi in the USA, is involved in an arbitration process with Merck, claiming that the latter's takeover of Schering-Plough constituted “a change of control” that would permit the ending of their marketing agreements regarding Simponi and the rheumatoid arthritis and Crohn’s disease blockbuster Remicade (infliximab). A decision was expected before year-end but the case is now likely to run into 2011.