Posted by Michael Wonder on 09 Jul 2022
FDA approves Krystexxa (pegloticase) injection co-administered with methotrexate, expanding the labelling to help more people with uncontrolled gout achieve a complete response to therapy
8 July 2022 - Approval based on MIRROR randomised controlled trial, which showed significant improvement and sustained patient response to Krystexxa with methotrexate compared to Krystexxa alone.
Horizon Therapeutics today announced that the U.S. FDA has approved the supplemental biologics license application expanding the labelling to include Krystexxa (pegloticase) injection co-administered with methotrexate, which will help more people with uncontrolled gout achieve a complete response to therapy.
