Boehringer Ingelheim Pharmaceuticals Inc’s New Drug Application (NDA) for its investigational compound nintedanib has been accepted for filing by the FDA and granted Priority Review designation.
The application for nintedanib is currently under review for the treatment of people with idiopathic pulmonary fibrosis (IPF), a rare, progressive and fatal lung disease that affects as many as 132,000 Americans. There are currently no FDA-approved treatments for IPF. The efficacy and safety of nintedanib in the treatment of IPF has not been established.
The FDA grants Priority Review designation for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment of serious conditions when compared to standard applications.
The NDA package includes results from two global Phase 3 studies (INPULSIS-1 and INPULSIS-2) evaluating the efficacy and safety of nintedanib in the treatment of IPF. The INPULSIS studies were recently presented at the American Thoracic Society (ATS) International Conference and published in the New England Journal of Medicine.
In June 2011, nintedanib was granted orphan-drug designation in the US Orphan-drug designation is a status given to a product intended for the treatment of a rare disease or condition. In June 2013, nintedanib was then granted Fast Track designation by the FDA. The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
“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,” said Tunde Otulana, MD, senior vice president, Clinical Development and Medical Affairs at Boehringer Ingelheim Pharmaceuticals, Inc. “If approved, nintedanib may offer a treatment option for people in the US who are living with this progressive disease, and have no approved treatment options today. We look forward to continuing to work closely with the FDA during this review period.”
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