Boehringer Ingelheim Reports the US FDA’s Acceptance of sNDA for Ofev (nintedanib) for Fibrosing Interstitial Lung Disease in Children and Adolescents
Shots:
- The US FDA has accepted its sNDA for Ofev (nintedanib) in children and adolescents aged 6-17yrs. with fibrosing interstitial lung disease (ILD)
- The sNDA was based on results from the P-III trial (InPedILD) evaluating the dose-exposure and safety of Ofev for 24wks., followed by open-label treatment in children and adolescents aged 6-17yrs. with clinically significant fibrosing ILD
- The results showed that a weight-based dosing regimen resulted in the exposure of nintedanib similar to adults and with a similar safety profile among children and adolescents with fibrosing ILD. The results were published in ERJ and presented at ERS International Congress 2022
Ref: PRNewswire | Image: Boehringer
Related News:- Boehringer Ingelheim’s Ofev (nintedanib) Receives NICE Recommendation for the Treatment of Idiopathic Pulmonary Fibrosis
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