J&J: applies to the FDA for an expanded indication for Simponi
(CercleFinance.com) - Johnson & Johnson today announced that it has applied to the US FDA for expanded approval of Simponi (golimumab) for the treatment of children aged 2 and over with moderately to severely active ulcerative colitis (UC), currently approved for adults.
The application is based on data from the PURSUIT program, which evaluated the drug's efficacy and safety in the pediatric population.
Hemorrhagic rectocolitis affects more than one million people in the United States, 20% of whom are children, underlining the importance of new therapeutic options adapted to young patients.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
The application is based on data from the PURSUIT program, which evaluated the drug's efficacy and safety in the pediatric population.
Hemorrhagic rectocolitis affects more than one million people in the United States, 20% of whom are children, underlining the importance of new therapeutic options adapted to young patients.
Copyright (c) 2024 CercleFinance.com. All rights reserved.