Abbott’s HUMIRA® (adalimumab) receives FDA approval for the treatment of ulcerative colitis

World Pharma News | Abbott (NYSE: ABT) announced that the U.S. Food and Drug Administration (FDA) has approved HUMIRA® (adalimumab) for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) when certain other medicines have not worked well enough. Combined with its approval to treat moderate to severe Crohn’s disease, HUMIRA is now approved for the treatment of two primary diseases that comprise inflammatory bowel disease (IBD).

HUMIRA works by inhibiting tumor necrosis factor-alpha (TNF-alpha). The UC approval represents the seventh indication for this treatment in the U.S. and makes HUMIRA the first and only self-administered biologic treatment approved for use in this disease. It is not known if HUMIRA is effective in people with moderate to severe UC who have lost response to or could not tolerate anti-TNF medicines. HUMIRA can be self-administered after proper injection training is received and with proper physician monitoring. “There is significant unmet medical need in this patient population, which has not seen a new treatment approved in more than seven years,” said William J. Sandborn, M.D., division chief, Gastroenterology, University of California, San Diego. “This FDA approval is good news for patients and health care professionals who are seeking another option to manage the disease.”

UC is a chronic disease that is marked by inflammation and ulceration in the lining of the colon or large intestine. It is estimated that approximately 700,000 people in the U.S. have UC. On average, people are diagnosed with UC in their mid-30s, though the disease can occur at any age. Symptoms include abdominal cramping, rectal bleeding, diarrhea, and urgency and frequency to have a bowel movement. The symptoms of UC tend to come and go, with periods of remission between flare-ups. Treatment may include medication and/or surgery.

It is also important that UC patients properly manage their nutrition because fluids, nutrients and electrolytes can be lost due to rectal bleeding and diarrhea. Additionally, 25 percent of UC patients will require surgery during the course of the disease.

“Since the first FDA approval of HUMIRA in late 2002, Abbott has continued to investigate the medication in multiple conditions with the goal of bringing this treatment option to more patients who may benefit from it,” said John M. Leonard, M.D., senior vice president, Global Pharmaceutical Research and Development, Abbott. “This approval underscores Abbott’s commitment to investing in and advancing our pipeline to benefit patients with IBD.”

About the HUMIRA UC Phase 3 Clinical Program
Abbott’s submission for HUMIRA was supported by results from two phase 3 studies, ULTRA 1, an 8-week study, and ULTRA 2, a 52-week study, both of which enrolled adult patients who had moderately to severely active UC despite concurrent or prior treatment with immunosuppressants (i.e., corticosteroids, azathioprine, or 6-mercaptopurine).

The primary endpoint of both studies was the proportion of patients achieving clinical remission at specified time points (week 8 in ULTRA 1 and weeks 8 and 52 in ULTRA 2). Remission was defined as a Mayo score of < 2 and no individual subscore > 1. The Mayo score is calculated based on subscores of stool frequency, rectal bleeding, physician’s global assessment and endoscopy. In the FDA-approved dose, both studies achieved their primary endpoints. The safety results from both studies were consistent with the known safety profile of HUMIRA and no new safety signals were identified.

About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.