J&J seeks approval for Simponi in ulcerative colitis
HORSHAM, Pa. — A subsidiary of Johnson & Johnson is hoping to win an additional approval for one of its drugs.
Janssen Biotech and Janssen Biologics B.V. announced the submission of a supplemental regulatory application to the Food and Drug Administration for Simponi (golimumab) for treatment of moderately to severely active ulcerative colitis, an inflammatory bowel disease that affects about 700,000 people in the United States. The drug already is approved for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
"We 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 for surgery," Janssen Research and Development VP and head of immunology development Jerome Boscia said.