Humira for the treatment of pediatric patients with moderately to severely active Crohn's disease, approved by FDA
The FDA ( Food and Drug Administration ) has approved Humira ( Adalimumab ) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease patients 6 years of age and older when certain other treatments have not worked well enough.
This FDA approval represents the eighth indication for Humira in the United States and makes it the first and only biologic treatment approved for use in this patient population that can be administered at home.
Crohn's disease is a type of inflammatory bowel disease ( IBD ) which commonly involves the end of the small intestine and the large intestine. Crohn's disease can appear at any age, but it is most often diagnosed in adolescents and young adults between 15 and 35 years of age.
Symptoms of pediatric Crohn's disease are similar to those in adults and can include abdominal pain, weight-loss and diarrhea. Additionally, when Crohn's disease is diagnosed in childhood, it may be more extensive than when it is diagnosed in adulthood.
Since there is no known cure for Crohn's disease, one of the treatment goals of pediatric Crohn's disease is to induce and maintain clinical remission.
In the United States, there are an estimated 38,000 children and teens with Crohn's disease.
Adalimumab works by inhibiting tumor necrosis factor-alpha ( TNF-alpha ) and can be self-administered after proper injection training is received and with appropriate physician monitoring.
In 2012, the European Commission approved Humira for the treatment of pediatric patients 6 to 17 years of age with severe active Crohn's disease who failed, are intolerant to, or have contraindications to conventional therapy.
The FDA approval was supported by the phase 3 IMAgINE-1 trial, which evaluated multiple dosing strategies of Humira to induce and maintain clinical remission in pediatric patients with moderately to severely active Crohn's disease for whom certain other treatments have not worked well enough.
IMAgINE-1 is the largest multi-center, randomized, double-blind anti-TNF trial in patients 6 to 17 years of age with moderately to severely active Crohn's disease conducted to date. ( Xagena )
Source: Abbvie, 2014