Priority Review for Boehringer's nintedanib

FDA accepted and granted Priority Review to an NDA from Boehringer Ingelheim GmbH (Ingelheim, Germany) for nintedanib ( BIBF 1120) to treat idiopathic pulmonary fibrosis (IPF). Boehringer declined to disclose the PDUFA date. An MAA for nintedanib is under accelerated assessment in the EU for IPF. The small molecule inhibitor of multiple pro-angiogenic kinases also is under review in Europe to treat advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma histology. ...