J&J, Schering-Plough Submit Application for Next-Generation TNF Inhibitor

Johnson & Johnson’s (J&J) subsidiary Centocor and Schering-Plough have submitted an application to the European Medicines Agency for golimumab, their next-generation tumor necrosis factor (TNF) inhibitor, for three indications: rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

If approved, the drug will compete with Amgen-Wyeth’s Enbrel (etanercept), Abbott Laboratories’ Humira (adalimumab) and J&J-Schering-Plough’s Remicade (infliximab), all of which are blockbusters.

Golimumab offers greater affinity and specificity in targeting and controlling TNF alpha, a protein that is present in larger quantities in patients with certain inflammatory conditions such as rheumatoid arthritis, J&J said. The product is being tested both in subcutaneous and IV formulations, but the European application is for subcutaneous injection only, with dosing every four weeks.