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FDA Grants Priority Review to Pulmonary Fibrosis Drug Nintedanib

Tyrosine kinase inhibitor targets growth factors

A new drug application (NDA) for the investigational compound nintedanib (Boerhinger Ingelheim) has been accepted for filing by the FDA and has been granted a “priority review” designation.

The application for nintedanib is currently under review for the treatment of patients with idiopathic pulmonary fibrosis (IPF) — a rare, progressive, and fatal lung disease that affects approximately 132,000 Americans. No FDA-approved treatments are currently available for IPF. The efficacy and safety of nintedanib in the treatment of IPF has not been established.

The FDA grants priority review designations for drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment of serious conditions compared with standard applications.

The NDA package includes results from two global phase III studies (INPULSIS-1 and INPULSIS-2) that evaluated the efficacy and safety of nintedanib in the treatment of patients with IPF. Data from the INPULSIS studies were recently presented at the American Thoracic Society (ATS) International Conference and were published in the New England Journal of Medicine.

In June 2011, nintedanib was granted an “orphan drug” designation in the U.S. This designation is given to products that are intended to treat a rare disease or condition. In addition, nintedanib was granted a “fast track” designation in June 2013. The FDA’s “fast track” program is designed to expedite the development and review of drugs designed to treat serious conditions and to fill an unmet medical need.

Nintedanib is an investigational small-molecule tyrosine kinase inhibitor (TKI) in development for the treatment of patients with IPF. The compound targets growth factors that have been shown to be potentially involved in pulmonary fibrosis (i.e., the vascular endothelial growth factor receptor [VEGFR], the fibroblast growth factor receptor [FGFR], and the platelet-derived growth factor receptor [PDGFR]).

IPF is characterized by progressive scarring of lung tissue (fibrosis) and by the loss of lung function over time. As the tissue thickens and stiffens with scarring, the lungs lose their ability to take in and transfer oxygen into the bloodstream, and vital organs do not receive enough oxygen. As a result, individuals with IPF experience shortness of breath and cough, and often have difficulty participating in everyday physical activities.

Source: Boehringer Ingelheim; July 2, 2014.

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