Boehringer Ingelheim says Phase III trials for its Ofev slowed progression of fatal lung disease
pharmafile | June 27, 2016 | News story | Research and Development, Sales and Marketing | Boehringer Ingelheim, drug trial, idiopathic pulmonary fibrosis, research
German drugmaker Boehringer Ingelheim said late-stage trials for its Ofev (nintedanib) to treat a fatal lung condition slowed progression of the disease.
The post-hoc analysis of the 1,061 patients has been published in the American Journal of Respiratory and Critical Care Medicine.
The trials included patients with idiopathic pulmonary fibrosis (IPF) but also those patients with a clinical diagnosis of IPF who, in the absence of a surgical lung biopsy and honeycombing on HRCT, had a possible UIP pattern and the presence of traction bronchiectasis.
Ganesh Raghu, Professor of Medicine, University of Washington, said: “This analysis confirms for the first time that disease progression and effect of treatment in a subgroup of patients not fully meeting the diagnostic criteria is similar to those meeting the current criteria, as defined in the 2011 international guidelines for diagnosis of IPF. This has implications to consider accepting the modified criteria, as used in this study for making a diagnosis of IPF that includes presence of possible UIP pattern and traction bronchiectasis in lower lobes (despite the absence of definite honeycombing on HRCT and surgical lung biopsy), in an appropriate clinical setting and in future clinical trials.”
Ofev is a small molecule tyrosine kinase inhibitor developed by Boehringer Ingelheim, is indicated for the treatment of IPF.
IPF is a debilitating and fatal lung disease with high mortality, affecting as many as 3 million people worldwide. Progression of IPF is variable and unpredictable, and over time the lung function of an IPF patient gradually and irreversibly declines. IPF causes permanent scarring or fibrosis of the lung, difficulty breathing and decreases the amount of oxygen the lungs can supply to major organs of the body.
Anjali Shukla
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