EMA accepts Boehringer’s accelerated marketing application for nintedanib in IPF

German family-owned pharma major Boehringer Ingelheim said this morning that the European Medicines Agency has accepted an accelerated marketing authorization application for the review of nintedanib, an investigational tyrosine kinase inhibitor (TKI) for the treatment of idiopathic pulmonary fibrosis (IPF).

“IPF is a debilatating and fatal lung disease with limited treatment options available that can slow disease progression,” said Charles de Wet, UK medical director at Boehringer Ingelheim, adding that the “EMA approval will bring this much needed therapy one step closer to patients, who will ultimately benefit.”

Clincial backing

The marketing 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 (p<0.001). 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 around 50% compared to patients taking placebo.