Vartagef filed with EU for Pulmonary Fibrosis - Boehringer

The European Medicines Agency has accepted an accelerated marketing authorisation application for the review of Vartagef (nintedanib), from Boehringer, for the treatment of idiopathic Pulmonary Fibrosis (IPF). The acceptance of this marketing authorisation application marks the beginning of the review process in the European Union for this potential new treatment.

The marketing authorisation application for nintedanib included results from two Phase III trials with identical design, INPULSIS-1 and INPULSIS-2, which showed that nintedanib significantly slowed disease progression in patients with IPF. Data from the two 52-week trials, recently published in the New England Journal of Medicine, demonstrate that nintedanib met the primary endpoint by significantly reducing the annual decline in forced vital capacity by approximately 50% compared to patients taking placebo.