Janssen Biologics B.V. announced that the company has withdrawn its application seeking a change to the Marketing Authorization for Simponi (golimumab) to add a new pharmaceutical form of intravenous (IV) administration for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). Janssen Biologics informed the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of its decision following receipt of an assessment report that indicated additional clinical data were required to further evaluate the risk to benefit profile of the I.V. formulation. “We have elected to withdraw our application seeking approval of Simponi I.V. in the European Union as we are unable at this time to provide additional clinical data beyond the pivotal Phase 3 results included in the current submission,” said Newman Yeilding, head of immunology development, Janssen Research & Development, LLC. “While we are disappointed that we will be unable to pursue the approval of Simponi I.V. as a treatment for moderately to severely active rheumatoid arthritis in the European Union, we are confident that the Phase 3 data accumulated through the Simponi I.V. clinical development program demonstrate a positive risk to benefit profile for this anti-tumor necrosis factor (TNF)-alpha therapy.”
The withdrawal of the Simponi IV application in the European Union (EU) has no impact on Simponi subcutaneous or intravenous formulations in approved indications worldwide and has no consequences on ongoing clinical trials.
Date: May 19, 2014
Source: Janssen
Filed Under: Drug Discovery
