OFEV (nintedanib), inhibitor of tyrosine kinases
PULMONOLOGY - New medicinal product
Opinions on drugs - Posted on Sep 10 2015
Reason for request
Minor improvement in the treatment of idiopathic pulmonary fibrosis in patients with a predicted FVC ≥ 50% and a DLco ≥ 30%.
- OFEV has a Marketing Authorisation in the treatment of idiopathic pulmonary fibrosis (IPF).
- Its efficacy has been demonstrated versus placebo in terms of improvement in predicted forced vital capacity (FVC): the level of the effect is moderate and reservations have been expressed in respect of the demonstration of its efficacy in relation to mortality, given the numerous methodological limitations.
- It provides a minor improvement only in patients with an FVC ≥ 50% and a diffusing capacity for carbon monoxide (DLco) ≥ 30%.
Improvement in actual benefit
Évaluation des médicaments