- AbbVie has received another FDA approval -- this time for the treatment of pediatric Crohn’s disease in patients as young as six.
- Although Crohn’s disease can appear at any time, it generally starts in young patients between the ages of 15 and 35.
- The clinical trial that supported the approval was a phase III study that enrolled patients between the ages of 6 and 17. The goal of the trial was to induce and maintain clinical remission.
Humira is the first and the only biologic that can be administered to Crohn’s disease patients at home. It is also the top-selling drug in the world -- at least for the moment.
With $11 billion in revenues (mainly based on its rheumatoid arthritis indication) in 2013, and an 18% increase in Q1 2014 sales compared with Q1 2013, Humira is continuing to perform above and beyond expectations. AbbVie has stated its intentions to continue to study Humira for additional applications in various immune-mediated inflammatory conditions.
AbbVie recently breathed a sigh of relief as a federal judge in Illinois dismissed claims that the company was guilty of racketeering by offering pharmacies discounts for branded products like Humira in order to bolster sales of the pricey blockbuster drug.