Posted by Michael Wonder on 07 Mar 2022
Horizon Therapeutics announces FDA has granted priority review of the supplemental biologics license application for the concomitant use of Krystexxa (pegloticase injection) plus methotrexate for people living with uncontrolled gout
7 March 2022 - Application based on recent MIRROR randomised controlled trial results, which showed 71% of patients randomised to receive Krystexxa plus methotrexate achieved a complete response.
Horizon Therapeutics today announced that the U.S. FDA granted priority review of the supplemental biologics license application to expand the label for Krystexxa plus methotrexate, an immunomodulator commonly prescribed by rheumatologists.
The Prescription Drug User Fee Act action date is 7 July 2022.
