Content about Colitis

SAN DIEGO — The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.

Santarus announced the approval of Uceris (budesonide) extended-release tablets for mild to active UC. The company plans to launch the drug in March.

LAS VEGAS — More patients with an inflammatory disease of the bowels responded to a drug used for autoimmune disorders than those taking a placebo, according to results of a late-stage clinical trial announced Monday.

Johnson & Johnson said phase-3 trial findings showed that "significantly" more patients with severely active ulcerative colitis responded to Simponi (golimumab), maintaining their responsiveness to the drug through the 54th week. The drug is already approved by the Food and Drug Administration for treating conditions like rheumatoid arthritis.

WASHINGTON — A panel of outside advisers to the Food and Drug Administration has backed wider use for Abbott Labs’ rheumatoid arthritis drug, Humira, for treating a type of inflammatory bowel disease.

According to published reports, the panel voted 15-2 that the benefits of Humira outweighed the risks in treating ulcerative colitis. However, the panel asked Abbott to conduct more studies upon Humira's approval.

NEW YORK — An organization focused on Crohn's disease and ulcerative colitis has revamped its website, the group said Tuesday.

The Crohn's and Colitis Foundation of America said it worked with Pittsburgh-based digital marketing agency BarkleyREI to redesign the website. The new site includes a section for people newly diagnosed with the diseases; a library that includes webcasts, brochures, fact sheets and videos; social media integration; pages listing local chapters and support groups; and other resources.

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is hoping to be the first to market a generic version of a drug used to treat ulcerative colitis, the company said.

Watson announced that it had filed with the Food and Drug Administration through a subsidiary for melamine delayed-release tablets, a generic version of Shire Development's Lialda, in the 1.2-g strength. Watson's filing included a Paragraph IV certification, a legal assertion that Lialda's patent protection is invalid, unenforceable or won't be infringed.

BURLINGTON, Mass. — The market for drugs to treat ulcerative colitis will increase from 2010's $1.7 billion to $3 billion in 2020, according to a new report by market research firm Decision Resources.

NEW YORK — Drug maker Warner Chilcott's diversified portfolio of drugs will help it weather generic challenges to its patents, according to a new report by Zacks Investment Research.

HORSHAM, Pa. — A panel of experts at the Food and Drug Administration has recommended that the agency approve a drug made by Johnson & Johnson as a treatment for ulcerative colitis in children.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for diarrhea caused by a bacterial infection.

The agency announced the approval of Optimer Pharmaceuticals’ Dificid (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea, also known as CDAD.

BURLINGTON, Mass. The drug market for ulcerative colitis treatments will see modest growth through 2019, according to a new report by Decision Resources.

The research and advisory firm said that the UC drug market will see growth of $800 million, driven by the uptake of Abbott and Eisai's Humira, Centocor Ortho Biotech/Merck/Mitsubishi Tanabe Pharma/Janssen's Simponi and Millennium's vedolizumab in the United States, France, Germany, Italy, Spain, United Kingdom and Japan.