European regulators will undertake an accelerated assessment of Boehringer Ingelheim's nintedanib for the treatment of the fatal lung disease idiopathic pulmonary fibrosis (IPF).
IPF is a debilitating illness caused by inflammation and scarring of the lungs for which, according to Charles de Wet, UK Medical Director at Boehringer Ingelheim, there are "limited treatment options available that can slow disease progression".
Nintedanib's marketing application includes data from two Phase III trials, INPULSIS-1 and INPULSIS-2, which showed that the tyrosine kinase inhibitor (TKI) is able to significantly hold back disease progression in patients with the disease and thereby meet an unmet medical need.
These trials showed that nintedanib significantly reduced the annual decline in forced vital capacity (FVC) by some 50% compared to patients taking placebo over 52 weeks, and key secondary endpoints - less deterioration in quality of life and a reduced risk of a first acute exacerbation - were also met.
If it gets the regulatory nod the drug will compete primarily with Intermune's Esbriet (pirfenidone), which has been on the market since 2011.
The European Medicines Agency is also currently reviewing nintedanib as a second-line therapy for non-small cell lung cancer (NSCLC).
EC OK for Pradaxa
Meanwhile, the groups also announced this morning that Pradaxa (dabigatran etexilate) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Pradaxa is as effective as warfarin but with significantly lower bleeding rates, a major advance for DVT and PE patients, and its the new approval makes the drug one of the most broadly indicated novel oral anticoagulants, says Boehringer.