Phadia announces launch of celiac disease tests
UPPSALA, Sweden Phadia on Thursday announced the launch of two new assays to support the accurate diagnosis of celiac disease.
“Our launch this month of EliA Gliadin IgA and EliA Gliadin IgG will offer physicians who suspect a possible case of celiac disease antibody tests with the lowest number of false positive results,” stated Stefan Eschbach, general manager of autoimmunity, Phadia. “This means avoiding putting patients through unnecessary biopsies.”
Celiac disease is a life-long condition in which ingestion of “gluten”, the water insoluble wheat-gliadin and the prolamins in rye and barley, leads to chronic inflammation and damage of the lining of the small intestine.
Approximately 1-out-of-every-250 people may have celiac disease, however, only 1-out-of-10 people with the disease may be actually be diagnosed, Eschbach noted. There may be as many 5 million worldwide with celiac disease.
A Mayo Clinic study published in last month’s issue of Gastroenterology reported that celiac disease is four times more common today than it was 50 years ago. Another key finding: Individuals who don’t realize they suffer from celiac disease (and therefore never received treatment for it) were four times more likely to have died during the study’s 45 years of monitoring versus individuals not affected by celiac disease.
Ulcerative colitis treatment reduces need for surgery by almost half, study suggests
NEW YORK A new study led by Mayo Clinic researchers found that ulcerative colitis patients had a 41% reduction in colectomy when treated with infliximab for one year, according to a study published in the October 2009 issue of Gastroenterology.
Ulcerative colitis, an inflammatory bowel disease that causes chronic inflammation of the colon, is characterized by abdominal pain and diarrhea. Like Crohn’s disease, another common IBD, ulcerative colitis can be debilitating and often lead to colectomy, or surgical removal of the colon.
In the study, 728 patients received placebo or infliximab (5 or 10 mg/kg) for 46 weeks and were monitored for hospitalization or surgical outcomes. Eighty-seven percent had complete follow-up for the endpoint of whether or not they had colectomy, while the remaining 13% of patients had follow-up for less then a year, with a median follow-up of 6.2 months in these patients. The research showed that treatment with infliximab at zero, two, six and then every 8 weeks, reduced the incidence of colectomy through 54 weeks by 41% in outpatients with moderately-to-severe active ulcerative colitis.
Infliximab is an artificial antibody that works by blocking tumor necrosis factor alpha, a chemical messenger and a key part of the immune reaction. Infliximab blocks the action of TNF alpha by preventing it from binding to its receptor in the cell.
“Our purpose in this study was to see if the use of infliximab for ulcerative colitis would reduce the need for surgery,” said William Sandborn, M.D., a Mayo Clinic gastroenterologist and lead author of the study. “We found that treatment with infliximab reduced the need for colectomy by 41% compared to patients treated with placebo.”
Previous research has shown that infliximab therapy induced clinical remission and bowel healing for colitis patients. This new research provides more information and options for patients struggling with this difficult disease, explained Sandborn.
FDA approves Perrigo’s laxative generic
ALLEGAN, Mich. Perrigo on Tuesday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter polyethylene glycol 3350, powder for solution, a generic equivalent to Schering-Plough’s MiraLAX laxative.
Perrigo said it would begin shipping immediately.
Estimated brand sales MiraLAX for the 12 months ended Aug. 28 were $200 million, Perrigo stated.