Pharma Focus America

FDA Accepts Supplemental New Drug Application for OFEV® (nintedanib) for Treatment of Fibrosing Interstitial Lung Disease in Children and Adolescents Aged 6-17 Years

Wednesday, July 26, 2023

Boehringer Ingelheim has announced that the U.S. Food and Drug Administration (FDA) accepted their supplemental New Drug Application (sNDA) for OFEV (nintedanib). The application aims to investigate the potential treatment of fibrosing interstitial lung disease (ILD) in children and adolescents between the ages of 6 to 17 years.

Prof. Robin Deterding, M.D., the Director of the Breathing Institute at Children's Hospital Colorado, emphasized the challenges faced by patients and families due to the lengthy and complex journey to diagnose childhood interstitial lung diseases. With no approved therapies currently available, this condition places a significant burden on affected individuals.

The sNDA submission is based on data from the InPedILD phase III trial, which assessed the dose-exposure and safety of OFEV in combination with standard of care for children and adolescents (aged 6-17) with clinically significant fibrosing ILD. The study utilized a weight-based dosing regimen, resulting in nintedanib exposure similar to that seen in adults, with a comparable safety profile. Diarrhea was the most common adverse event observed with nintedanib compared to the placebo. The complete results were published in the European Respiratory Journal and presented at the European Respiratory Society International Congress in September 2022.

Craig Conoscenti, M.D., FCCP, ATSF, Executive Director/Therapeutic Area Head, Respiratory IPF/ILD, Clinical Development and Medical Affairs at Boehringer Ingelheim, reaffirmed the company's dedication to respiratory innovation and providing life-changing treatments for pulmonary fibrosis patients, including those with childhood interstitial lung disease. Boehringer Ingelheim looks forward to working with the FDA to potentially make OFEV the first approved treatment for children and adolescents aged 6-17 years with fibrosing interstitial lung disease.

Childhood interstitial lung disease (chILD) is a rare condition encompassing over 200 disorders. The exact prevalence of chILD is unknown, and pulmonary fibrosis within this condition is even rarer, with limited diagnostic criteria and management guidelines available.

The InPedILD trial (NCT04093024) is an exploratory phase III double-blind, randomized, placebo-controlled study that assessed nintedanib's dose-exposure and safety in combination with standard of care for 24 weeks, followed by open-label treatment with nintedanib for a variable duration in children and adolescents aged 6-17 years with clinically significant fibrosing ILD. This trial is among the first to focus on childhood interstitial lung diseases and showed promising outcomes.

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