OFEV® (nintedanib) was approved for the EU market as a new drug for the treatment of IPF on January 15th 2015. This decision was made on the basis of the large-scale replicate Phase III INPULSIS® trials. These studies involved 1066 patients from 24 countries and evaluated the effect of oral nintedanib over 52 weeks. The data showed a slowing of IPF progression under OFEV® (decline in lung function reduced by 50%) and incidence of adjudicated acute exacerbations* reduced by 68%.1 OFEV® offers an alternative to Esbriet® (pirfenidone), which has been available for the treatment of IPF in the EU since 2011.
Previously, in October 2014, both medications had also received simultaneous approval by the FDA for the US market.2,3 This approval added significantly to the spectrum of therapy options for the treatment of IPF in the US.
The use of nintedanib and pirfenidone is now recommended conditionally for the treatment of patients with IPF.4** To find out more about the updated IPF management guidelines, visit our management chapter.
To find out more detailed information on OFEV®, please visit the product website.
*Adjudicated exacerbations was a pre-specified sensitivity analysis in the pooled data set. Time to first investigator-reported exacerbation was a secondary endpoint which was met in TOMORROW and INPULSIS®-2 but not in INPULSIS®-1.
**This conditional recommendation means that clinicians are encouraged to discuss preferences with their patients when making treatment decisions.