Janssen pulls EU application for IV Simponi

Janssen Biologics, a European subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), says it has withdrawn its application to change the marketing authorization for Simponi (golimumab) to add a new form of intravenous (IV) administration for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

Janssen Biologics informed the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) of its decision following receipt of an assessment report that indicated additional clinical data were required to further evaluate the risk:benefit profile of the IV formulation.

"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," said Newman Yeilding, head of immunology development at Janssen Research & Development, adding: "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 program demonstrate a positive risk:benefit profile for this anti-tumor necrosis factor (TNF)-alpha therapy."