Boston, MA 09/26/2014 (wallstreetpr) – AbbVie Inc (NYSE:ABBV)’s drug HUMIRA® (adalimumab) has gained authorization from the U.S. Food and Drug Administration to treat children suffering from Crohn’s disease if they fail to show significant improvements from currently available treatment means.
Alternative Treatment
According to PR Newswire news, the company announced its latest achievement with HUMIRA yesterday. The FDA has allowed AbbVie Inc (NYSE:ABBV) to use the drug as a treatment option for pediatric patients (6+ years old children) showing symptoms of Crohn’s disease. Patients who have demonstrated moderate or severe conditions of Crohn’s disease and have failed to produce a satisfactory response to immunomodulators or corticosteroids can avail the treatment.
Crohn’s disease is typically an inflammatory bowel disease which is concerned with the end of both the intestines. Although it can occur to people of any age group, it is found to be more common among children and adolescents. In the U.S., as many as 38,000 pediatric patients have been recorded. However, as of now, no cure for the disease exists.
AbbVie Inc (NYSE:ABBV)’s HUMIRA has shown significant success in reducing symptoms and signs of disease. The drug has helped in achieving and maintaining clinical remission. The treatment works by essentially preventing tumor necrosis factor-alpha. It is capable of self-administration after appropriate injection training has been received, in addition to proper guidance of a physician.
A Milestone Achievement
The FDA license represents the eighth indication for the drug adalimumab. It is the first and only biological therapy that can be administered at home to have gained approval for use in children.
HUMIRA had gained approval to be used to treat pediatric patients between age range of 6 and 17 years in the European Union in 2012. The indication was to treat patients suffering from severe and active Crohn’s disease who did not show any improvements with previously available therapies. It was also allowed to cater to children who demonstrated contraindications or were intolerant to conventional treatments.
