Abbott has simultaneously submitted a supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) 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.
Crohn's disease is a serious, chronic inflammatory disease of the gastrointestinal (GI) tract that affects more than one million people in North America and Europe combined. Currently, there is no cure for Crohn's disease, reinforcing the need for safe and effective treatment options that will help patients maintain control of their disease, an Abbott release stated.
"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," said Stephen Hanauer, M.D., Professor of Medicine and Clinical Pharmacology Chief, Section of Gastroenterology and Nutrition, University of Chicago.
The global filings are based on the results of three randomized, double-blind, placebo-controlled, multi-centre trials of Humira - 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) and GAIN (Gauging Adalimumab effectiveness in Infliximab Nonresponders).
Clinical trials have been completed evaluating the efficacy and safety of HUMIRA in a range of moderate-to-severe Crohn's disease patients, from those who were naïve to anti-TNF therapy to patients who had previously lost response or were unable to tolerate infliximab. In these trials, Humira demonstrated statistical significance in inducing and maintaining clinical remission in patients with moderate-to-severe Crohn's disease. In the study evaluating the ability of Humira to maintain remission, a proportion of patients in clinical remission were able to discontinue steroid use.