Abbott (NYSE: ABT) has simultaneously submitted a supplemental Biologics License Application (sBLA) with the USFDA and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA® (adalimumab) as a treatment for moderate-to-severe Crohn's disease.
There is currently no cure for Crohn’s disease, a serious, chronic inflammatory disease of the gastrointestinal (GI) tract affecting more than one million people in North America and Europe combined. There is therefore a strong need for safe and effective treatment options that will help patients control Crohn’s disease.
According to Stephen Hanauer, M.D., Professor of Medicine and Clinical Pharmacology Chief, Section of Gastroenterology and Nutrition, University of Chicago:
"HUMIRA may offer much-needed hope to physicians, as well as to people living with Crohn's disease, who have had limited, effective, long-term treatment options.”
Several global clinical trials have been completed that evaluated the efficacy and safety of HUMIRA® in a range of moderate-to-severe Crohn's disease patients:
- CLASSIC I: CLinical assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn's disease
- CHARM: Crohn's trial of the fully Human antibody Adalimumab for Remission Maintenance
- GAIN: Gauging Adalimumab effectiveness in Infliximab Nonresponders
In these trials, HUMIRA showed statistical significance in inducing and maintaining clinical remission in patients with moderate-to-severe Crohn's disease.
HUMIRA is the only USFDA-approved fully human monoclonal antibody for the reduction of the signs and symptoms (inducing major clinical response, inhibiting the progression of structural damage, and improving physical function) in adult patients with moderately-to-severely active rheumatoid arthritis (RA), in combination with methotrexate (MTX) or other disease-modifying anti- rheumatic drugs (DMARDs).
In addition, HUMIRA® in the United States is indicated for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis.
Find more details at Abbott’s press release.
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