Janssen Biotech and Janssen Biologics have submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of Simponi (golimumab).
The drug is used to treat adult patients with moderately to severely active ulcerative colitis (UC).
Janssen Research and Development, Immunology Development head Jerome Boscia said they are pleased to bring forward submissions for Simponi as a potential therapeutic option for patients who fail to respond to conventional treatments and who face the continued debilitating effects of living with ulcerative colitis, and in some circumstances, a decision of surgery.
"We look forward to collaborating with the health authorities on these submissions seeking approval of SIMPONI as a subcutaneously administered anti-tumor necrosis factor-alpha treatment for moderately to severely active ulcerative colitis," Boscia added.
Simponi received approvals in the US, Canada and the EU in 2009 for three rheumatic indications simultaneously, becoming the first subcutaneous anti-tumor necrosis factor (TNF)-alpha therapy.
Both the applications are supported by safety findings from the Programme of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT).