Posted by Michael Wonder on 26 Apr 2020
Janssen announces submission of two applications to U.S. FDA seeking approval of Simponi Aria (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
24 April 2020 - Submissions demonstrate Janssen’s commitment to developing new options for young patients.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of two supplemental biologics license applications to the U.S. FDA seeking approval of Simponi Aria (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis, in patients two years of age and older in combination with methotrexate.
If approved for these indications, SIMPONI ARIA would be the first anti-tumour necrosis factor-alpha biologic agent administered by intravenous infusion available for the treatment of these juvenile arthritides.
