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Recent approvals: OFEV® (nintedanib) approved in the EU for the treatment of IPF

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%. 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. This approval added significantly to the spectrum of therapy options for the treatment of IPF in the US.

Update of IPF management guidelines in 2015

The use of nintedanib and pirfenidone is now recommended conditionally for the treatment of patients with IPF. 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.

For more information on both drugs, please refer to the European Medicines Agency (EMA) for the OFEV® Summary of Product Characteristics and the Esbriet® Summary of Product Characteristics

*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.

  1. Boehringer Ingelheim. OFEV® (nintedanib*) approved in the EU for the treatment of IPF. Available at: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/19_january_2015_ipf.html. Accessed March 4, 2015.
  2. Boehringer Ingelheim. Boehringer Ingelheim’s OFEV® (nintedanib*) approved by the FDA for the treatment of idiopathic pulmonary fibrosis Available at: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/16_october_2014.html. Accessed March 4, 2015.
  3. US Food & Drug Administration. FDA approves Esbriet to treat idiopathic pulmonary fibrosis. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418991.htm. Accessed March 4, 2015.
  4. Raghu G., et al. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline. Am J Respir Crit Care Med 2015;192:e3–e19.