J&J: Fast Track designation for nipocalimab
(CercleFinance.com) - Johnson & Johnson announces that the US FDA has granted 'Fast Track' (FTD) designation to nipocalimab for the treatment of adult patients with moderate to severe Sjögren's disease (SjD).
This 'Fast Track' designation is designed to accelerate the availability of new therapies by facilitating the development and speeding up the review of the drugs concerned.
The company also points out that at the end of 2024, nipocalimab had already been granted Breakthrough Therapy (BTD) status by the same FDA.
J&J reports that a Phase II study presented in 2024 had met its primary endpoint showing an average relative improvement of over 70% in systemic disease activity at week 24 with nipocalimab versus placebo.
Trends of improvement were similarly observed across several secondary endpoints, and safety and tolerability were consistent with other clinical studies of nipocalimab, the laboratory concludes.
Copyright (c) 2025 CercleFinance.com. All rights reserved.
This 'Fast Track' designation is designed to accelerate the availability of new therapies by facilitating the development and speeding up the review of the drugs concerned.
The company also points out that at the end of 2024, nipocalimab had already been granted Breakthrough Therapy (BTD) status by the same FDA.
J&J reports that a Phase II study presented in 2024 had met its primary endpoint showing an average relative improvement of over 70% in systemic disease activity at week 24 with nipocalimab versus placebo.
Trends of improvement were similarly observed across several secondary endpoints, and safety and tolerability were consistent with other clinical studies of nipocalimab, the laboratory concludes.
Copyright (c) 2025 CercleFinance.com. All rights reserved.