ARIAD Initiates Submission Of NDA For Brigatinib To FDA Ahead Of Plan

(RTTNews) - ARIAD Pharmaceuticals Inc. (ARIA) announced the initiation of a New Drug Application or NDA submission for its investigational anaplastic lymphoma kinase or ALK inhibitor, brigatinib, to the U.S. Food and Drug Administration or FDA.

ARIAD is seeking U.S. marketing approval of brigatinib for patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib. Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK+ NSCLC.

The Company is seeking accelerated approval for brigatinib from the FDA and plans to request a priority review of the application.

ARIAD's NDA is a rolling submission which will occur in three parts. The initial submission contains all nonclinical portions of the NDA and will be followed by submissions of the chemistry, manufacturing and controls (CMC) and clinical data. The rolling NDA submission is expected to be complete in the third quarter of 2016.