Data from trials of Vargatef (nintedanib) in idiopathic pulmonary fibrosis published in Respiratory Medicine- Boehringer

Pooled analysis from the TOMORROW and INPULSIS trials, recently published in Respiratory Medicine, confirmed that Ofev or Vargatef (nintedanib), from Boehringer, reduces the risk of acute exacerbations by approximately 50% in people with idiopathic pulmonary fibrosis (IPF), a rare and serious lung disease. An acute exacerbation, a sudden worsening in respiratory function without warning or known cause, is a leading cause of hospitalization for people with IPF. Around half of all people hospitalized because of an acute IPF exacerbation die during hospitalization.

The findings also showed that OFEV slowed disease progression by approximately 50% across the range of patient types in the clinical trial program and reduced the risk of death. The pooled analysis is based on data from the Phase II TOMORROW trial and the two Phase III INPULSIS trials that included a total of 1,231 people with IPF (723 treated with OFEV, 508 treated with placebo). A separate meta analysis was conducted to summarize the data from all three trials examining OFEV efficacy and safety. Data from these three clinical trials formed the basis for the approval of OFEV in the United States, Europe, Japan and other countries worldwide.

Comment: Pirfenidone (Esbriet) from Intermune/Roche is a competitor to nintedanib and both Esbriet and Ofev are US approved to treat Idiopathic Pulmonary Fibrosis.

See: "Nintedanib in patients with idiopathic pulmonary fibrosis: Combined evidence from the TOMORROW and INPULSIS trials" Luca Richeld et al. Respiratory Medicine, February 02, 2016 DOI: http://dx.doi.org/10.1016/j.rmed.2016.02.001