Simponi approved in Europe
pharmafile | October 8, 2009 | News story | Sales and Marketing |Â Â RA, Simponi, TNFÂ
Rheumatic disease drug Simponi has received marketing approval for Europe, where it will be marketed by Schering-Plough.
The drug is indicated for moderate-to-severe active rheumatoid arthritis (RA), active and progressive psoriatic arthritis (PsA) and severe, active ankylosing spondylitis (AS).
It was jointly developed by Schering-Plough and Centocor, the Johnson & Johnson subsidiary behind blockbuster anti-TNF arthritis treatment Remicade.
Described by Schering-Plough as “one of the five stars in our development pipeline”, Simponi (golimumab) is a follow-on product, which analysts predict will replicate Remicade’s commercial status.
The first once-monthly anti-tumor necrosis factor (TNF)-alpha therapy that can be administered by patients, it received a positive opinion from the CHMP in June.
In April this year Simponi was approved by the US Food and Drug Administration and Health Canada for all three conditions.
“Simponi will provide an important and convenient new treatment option to rheumatologists and their patients,” said Thomas Koestler, president of Schering-Plough Research Institute.
It comes in either SmartJect form or as a prefilled syringe and has been demonstrated to significantly reduce the signs and symptoms of the diseases.
In the European Union it can be used as a 50 mg subcutaneous injection in combination with methotrexate for adult RA and PsA patients who have not responded to disease-modifying anti-rheumatic drug therapy.
Simponi has been shown to improve physical function for these patients, and can also be used to treat adult AS patients who have responded inadequately to conventional therapy.
The TNF blocker class currently comprises the market leaders of Amgen/Wyeth’s Enbrel, Remicade and Abbott’s Humira, UCB’s newer treatment Cimzia and now Simponi.
In August the FDA ruled that they should all carry new warnings of the increased risk of certain cancers for children and adolescents taking the treatment.
The decision came after a year-long review of data found they raised the risk of lymphoma and other cancers.
Centocor has exclusive marketing rights to Simponi in the US, while Schering-Plough is set to have them in most other countries.
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