FDA Grants Priority Review To Boehringer Ingelheim's Nintedanib NDA In IPF
Boehringer Ingelheim reported that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for nintedanib as treatment for idiopathic pulmonary fibrosis. The FDA also granted Priority Review designation to Boehringer Ingelheim’s application.
Nintedanib is an investigational small molecule tyrosine kinase inhibitor (TKI) that targets growth factors implicated in pulmonary fibrosis. These are the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR).
Tunde Otulana, SVP of Clinical Development and Medical Affairs at Boehringer Ingelheim Pharmaceuticals, said, “This is an exciting and important next step in the review of nintedanib for the treatment of IPF, which is a serious disease with a high unmet medical need. If approved, nintedanib may offer a treatment option for people in the U.S. who are living with this progressive disease and have no approved treatment options today.” Otulana stated that the company anticipates working closely with the agency during its NDA priority review period.
Idiopathic pulmonary fibrosis is a chronic, debilitating, progressive and ultimately life-threatening disease characterized by progressive scarring of lung tissue and loss of lung function in the long term. Patients with IPF experience breathlessness, cough, and difficulty taking part in daily physical activities. The disease is estimated to affect up to 132,000 patients in the U.S. There are currently no FDA-approved treatment options for IPF.
The NDA for nintedanib is supported by positive results from two global Phase III studies that determined the drug’s safety and efficacy in the treatment of patients with IPF. The FDA designates Priority review to an application that has potential to significantly improve safety and efficacy of treatment of serious conditions compared to standard applications.
Earlier this month, the company also announced the launch of an expanded access program (EAP) for nintedanib for patients with IPF.