Merck Reports CHMP Positive Opinion For SIMPONI - Quick Facts

(RTTNews) - Drug maker Merck & Co., Inc. (MRK) Tuesday said SIMPONI (golimumab) has received CHMP positive opinion for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis or nr-axial SpA with objective signs of inflammation, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs or NSAIDs.

Once the EU commission issues their EC decision, and if approved, nr-axial SpA patients can be considered for the once-monthly subcutaneous injection with SIMPONI.

The CHMP positive opinion was based on the findings from the GO-AHEAD study, which demonstrated significant clinical improvement in patients with active nr-axial SpA treated with golimumab, compared with patients treated with placebo, over 16 weeks.