European Medicines Agency Accepts Accelerate?d Marketing Authorisat?ion Applicatio?n for Nintedanib? in IPF

Boehringer Ingelheim has announced that the European Medicines Agency (EMA) has accepted an accelerated marketing authorisation application for the review of nintedanib*, an investigational tyrosine kinase inhibitor (TKI) for the treatment of idiopathic pulmonary fibrosis (IPF).[1] The acceptance of this marketing authorisation application marks the beginning of the review process in the European Union for this potential new treatment.

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

The marketing authorisation application for nintedanib* included results from two Phase III trials with identical design, INPULSIS(TM)-1 and INPULSIS(TM)-2, which showed that nintedanib* significantly slowed disease progression in patients with IPF (p<0.001).[2] 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.[2]

Nintedanib*, taken as one capsule twice daily, is the first targeted treatment for IPF that has consistently demonstrated the ability to slow disease progression by significantly reducing decline in lung function (p<0.001) with a manageable side effect profile.[2]

* Nintedanib is an investigational compound. Its safety and efficacy have not yet been
fully established.

References

[1] Richeldi L, Costabel U, Selman M. Efficacy of a Tyrosine Kinase inhibitor in Idiopathic Pulmonary Fibrosis. N Engl J Med 2011; 365:1079-1087.

[2] Richeldi L, Du Bois R, Raghu G et al. Efficacy and Safety of nintedanib in Idiopathic Pulmonary Fibrosis. N Engl J Med 2014; published online 18 May: DOI: 10.1056/NEJMoa1402584