Ulcerative Colitis J&J seeks approval Simponi
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.
About Ulcerative Colitis
Ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD) affecting 2.5 million individuals worldwide, is marked by the inflammation and ulceration of the colonic mucosa, or innermost lining, which may lead to bloody stools, severe diarrhea and frequent abdominal pain. Tiny open sores, or ulcers, form on the surface of the lining, where they bleed and produce pus and mucus. Symptoms of the disease may lead to loss of appetite, subsequent weight loss and fatigue. On average, people are diagnosed with UC in their mid-30s, but the disease can occur at any age. Between 25 and 40 percent of people living with UC will require surgery at some point in their life. UC is a chronic disease, and there is no cure. Although progress has been made in IBD research, researchers do not know what causes this disease.