Simponi approved in Canada
pharmafile | April 16, 2009 | News story | Research and Development, Sales and Marketing |Â Â J&J, JJ, SimponiÂ
Johnson & Johnson's monoclonal antibody Simponi has been given regulatory approval in Canada.
Simponi (golimumab) has been given the green light in combination with methotrexate, for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
The drug is a follow-on to Remicade, which had sales of $2.1 billion last year. The once-monthly, subcutaneous therapy is expected to gain similar blockbuster status.
The drug, marketed jointly by J&J subsidiary Centocor and Schering-Plough will be available in Canada from the second half of this year.
Jerome Boscia, senior vice president at Centocor said: "The first approval marks a major milestone in the clinical development programme for Simponi.
"The approval of Simponi expands the therapeutic options for physicians and offers patients an effective new medication that can be self-administered once monthly."
Simponi was filed with the FDA and European regulators last year and is also being studied as an intravenous infusion therapy for the treatment of rheumatoid arthritis.
The human monoclonal antibody targets TNF-alpha, the protein that can cause inflammation and damage to bones, cartilage and tissue.
But analysts Datamonitor has warned that issues around Schering-Plough's partnership with J&J need to be sorted out in order for Merck to maximise its potential earnings in the proposed merger.
Schering-Plough is due to market both Remicade and Simponi outside the US and Japan and Merck will inherit these rights once the proposed deal is finalised.
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