On Thursday, Johnson & Johnson (JNJ 0.23%) announced that its Janssen Biotech and Janssen Biologics subsidiaries have submitted applications in the U.S. and Europe regarding the use of their Stelara psoriasis drug.
A supplemental Biologics License Application was submitted to the FDA and a Type II Variation was submitted to the European Medicines Agency.
The new usage will be for the treatment of adult patients with active psoriatic arthritis, a chronic, debilitating immune-mediated inflammatory disease affecting more than 2 million patients in the U.S., an estimated 4.2 million patients in Europe, and perhaps as many as 37 million people worldwide.
Johnson & Johnson noted that its twin applications are support by findings from a Phase 3 clinical trial. The company further noted that this same drug is currently in Phase 3 development for the treatment of moderately to severely active Crohn's disease.
