arbitration settlement out of the Schering-Plough transaction -- in Europe, but not the US.
CHMP granted a thumbs up to an expanded nr-axial SpA indication, which supplements a number of existing indications in rheumatology and gastroenterology. That's some good news for Merck. From the press release then, a bit:
. . . .Merck today announced that SIMPONI (golimumab) has received CHMP positive opinion for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (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 (golimumab).
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. . . .
And so -- onward we go.