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OFEV (nintedanib), inhibitor of tyrosine kinases

PULMONOLOGY - New medicinal product
Opinions on drugs - Posted on Sep 10 2015

Reason for request

Inclusion

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%.

Actual benefit

Modéré

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Improvement in actual benefit

IV (mineur)

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Therapeutic use

-

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