SUNDAY, JUNE 17, 2018

Ulcerative colitis drug receives FDA approval

Janssen Biotech, Inc., announced on Wednesday that it received FDA approval for its ulcerative colitis drug SIMPONI.

Ulcerative colitis is a chronic inflammatory bowel disease that causes inflammation, and sometimes ulceration, of the colonic regions. This leads to bloody stools, severe diarrhea and frequent abdominal pain. There are as many as 700,000 people affected by UC in the United States alone.

SIMPONI is the first subcutaneous biological treatment for UC that has been approved by the FDA. SIMPONI is a human antibody that works by targeting excess TNF-alpha, a protein that when overproduced causes UC, and neutralizes the excess proteins.

"The FDA approval of SIMPONI brings an important, new subcutaneous therapeutic option to adults living with moderate to severe ulcerative colitis, a disease where treatment options have been limited," William Sandborn, professor and chief of the Division of Gastroenterology at the University of California, San Diego School of Medicine and lead study investigator, said.

In the trials run, SIMPONI showed to induce clinical remission in the patients. It was also shown to improve and maintain endoscopic appearance of the mucosa when taken.

"SIMPONI has demonstrated significant benefits in the treatment of ulcerative colitis, a chronic inflammatory bowel disease, and represents a meaningful addition to the treatment armamentaria for gastroenterologists," Sandborn said.