FDA Grants Roche’s Esbriet Priority Review for Unclassifiable Interstitial Lung Disease
The FDA has granted Roche a Priority Review for Esbriet (pirfenidone) as a treatment for unclassifiable interstitial lung disease (UILD).
The agency previously approved Esbriet in 2014 for idiopathic pulmonary fibrosis and last year granted the product Orphan Drug and Breakthrough Therapy designations for UILD.
The FDA is expected to make a decision on Roche’s supplemental New Drug Application by May. Roche earned approximately $1.24 billion in worldwide sales of Esbriet in 2019.