FDA accepts Boehringer’s nintedanib NDA; granted priority review for IPF

The US subsidiary of German family-owned drug major Boehringer Ingelheim says that the New Drug Application for its investigational compound nintedanib has been accepted for filing by the US Food and Drug Administration 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, 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 USA 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,” he added.