Boehringer Ingelheim Reports Results of OFEV in P-III (InPedILD) Study for the Treatment of Fibrosing Interstitial Lung Disease
Shots:
- The P-III (InPedILD) study evaluates PK & safety of nintedanib (OFEV) in children & adolescents (aged 6-17yrs.) with clinically significant fibrosing ILD for 24wks. Boehringer Ingelheim will also submit an application to the US FDA & EMA
- The PK results of the study indicated the weight-based dosing regimen of nintedanib resulted in comparable exposure & also showed an acceptable safety & tolerability profile with no new safety signals observed in children/adolescents vs. adults with IPF, PF-ILD & SScILD
- Earlier, OFEV has been approved in the US and 80 other countries for the treatment of IPF & was approved in the US to slow the rate of decline in pulmonary function in patients with SSc-ILD in Sep’19 & for chronic fibrosing ILDs in Mar’20
Ref: PRNewswire | Image: Boehringer Ingelheim
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