Nintedanib (Ofev, 6) – Ofev®
Interstitial lung disease with systemic sclerosis, 6 to < 18 years of age
Characteristics
| Start date | 15.02.2025 – Marketing authorisation: 12.02.2025 |
|---|---|
| Resolution | 07.08.2025 |
| INN | Nintedanib |
| Brand name | Ofev® |
| Pharm. company | Boehringer Ingelheim Pharma GmbH |
| G-BA Procedure ID | D-1157 |
| ATC code | L01EX09 Other protein kinase inhibitors (L01EX) |
| Therapeutic area | Respiratory system diseases |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
Studies and Results
- Clinical trials
- In the dossier for the benefit assessment, the pharmaceutical manufacturer submitted the results of the InPedILD study. This was a randomised, double-blind, parallel-group study comparing nintedanib with placebo, both administered in addition to standard therapy at the discretion of the doctor.
Children and adolescents aged 6 to 17 years with interstitial lung disease associated with systemic sclerosis (SSc-ILD)
- An additional benefit is not proven for children and adolescents aged 6 to 17 years with interstitial lung disease associated with systemic sclerosis (SSc-ILD).
- An additional benefit of nintedanib is not proven.
- The pharmaceutical manufacturer states that the InPedILD study included only 7 children and adolescents with interstitial lung disease associated with systemic sclerosis and that, due to the small number of children and adolescents, no conclusions can be drawn for the assessment of additional benefit.
- Consequently, the pharmaceutical manufacturer did not prepare any data for the dossier relating to this specific question.
- Consequently, there are no suitable data available to assess the additional benefit of nintedanib for children and adolescents aged 6 to 17 years with interstitial lung disease associated with systemic sclerosis.
Courtesy translation only, please refer to the German original.
Associated procedures
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