
Janssen abandons Simponi application
pharmafile | May 23, 2014 | News story | Sales and Marketing | Europe, Janssen, RA, Simponi, rheumatoid arthritis
Janssen Biologics has withdrawn its application to add an intravenous (IV) form to the marketing authorisation of veteran rheumatoid arthritis (RA) drug Simponi in Europe.
The company was ‘disappointed’ to abandon its intended extension of Simponi (golimumab), a tumour necrosis factor (TNF) inhibitor, but admits it simply does not have the information to support the change.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued an assessment report indicating that additional clinical data were required ‘to further evaluate’ how safe and effective an IV formulation would be.
“We have elected to withdraw our application seeking approval of Simponi IV in the European Union as we are unable at this time to provide additional clinical data beyond the pivotal Phase III results included in the current submission,” says Newman Yeilding, Janssen R&D’s head of immunology development.
At present, Simponi is approved as a once-monthly treatment – administered either by pre-filled pen or syringe – in Europe for moderately to severely active RA, active psoriatic arthritis, active ankylosing spondylitis and moderate to severe ulcerative colitis (UC).
“While we are disappointed that we will be unable to pursue the approval of Simponi IV as a treatment for moderately to severely active rheumatoid arthritis in the European Union, we are confident that the Phase III data accumulated through the Simponi IV clinical development programme demonstrate a positive risk/benefit profile for this anti-TNF-alpha therapy,” he adds.
Janssen insists that this setback has no effect on subcutaneous formulations of Simponi or of IV versions in other approved indications.
The TNF-alpha protein can cause inflammation and damage to bones, cartilage and tissue when it is overproduced in the bodies of sufferers from chronic inflammatory diseases.
Schering-Plough (Ireland), a subsidiary of Merck, has distribution rights to Simponi in Europe while Janssen Biotech markets Simponi in the US.
Adam Hill
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