Merck has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Simponi (golimumab) to treat adult patients with severe and active non-radiographic axial spondyloarthritis (nr-axial SpA).
Simponi is a human monoclonal antibody, which targets and neutralises tumour necrosis factor (TNF) alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue.
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Simponi received CHMP positive opinion to treat nr-axial SpA patients 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).
Merck immunology clinical research vice-president Dr Sean Curtis said: “The indication of Simponi in non-radiographic axial spondyloarthritis will add to a number of existing indications in rheumatology and gastroenterology.”
The CHMP positive opinion was based on the results of the Go-Ahead study that showed significant clinical improvement in patients with active nr-axial SpA treated with golimumab compared against patients treated with placebo over 16 weeks.
Go-Ahead was a Phase IIIb double-blind, randomised and placebo-controlled trial carried out in patients 18 to 45 years of age with active nr-axial SpA, and diagnosed according to the ‘Assessment in Ankylosing Spondylitis’ (ASAS) criteria.
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By GlobalDataThe trial assessed 197 patients who were treated with either golimumab 50mg or placebo subcutaneous injections every four weeks. Its primary endpoint is the percentage of patients who attained ASAS20 at week 16.
Janssen Biotech discovered and developed Simponi and sells the product in the US, while the Janssen Pharmaceutical Companies market it in Canada, Central and South America, the Middle East, Africa, and Asia-Pacific.
Mitsubishi Tanabe Pharma holds distribution rights to the drug in Japan, Indonesia, and Taiwan, while Merck’s subsidiary Schering-Plough (Ireland) company has distribution rights for Simponi in Europe, Russia and Turkey.
