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2 Jul 2014

FDA Accepts NDA Filing for Boehringer Ingelheim's Investigational Nintedanib

Boehringer Ingelheim Pharmaceuticals, Inc. has announced that the New Drug Application (NDA) for its investigational compound nintedanib has been accepted for filing by 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.


"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."


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.


In June 2011, nintedanib was granted orphan-drug designation in the US.


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