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# sNDA for Esbriet in Lung Disease Gets Priority Review
- URL: https://www.fdaweb.com/snda-for-esbriet-in-lung-disease-gets-priority-review/
- Published: 2021-01-21T12:00:00.000Z
- Updated: 2026-09-14T16:43:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148496

FDA has accepted for priority review a Genentech supplemental NDA for Esbriet (pirfenidone) for treating unclassifiable interstitial lung disease. The agency is expected to make a review decision in May. Esbriet was originally approved in 2014 for treating idiopathic pulmonary fibrosis.

The submission is based on data from a pivotal, 24-week Phase 2 trial, which showed that over 24 weeks Esbriet treatment was associated with less loss of lung function and exercise capacity compared with placebo, according to Genentech. Interstitial lung disease (ILD) broadly describes more than 200 types of rare pulmonary diseases, it says. ILDs share similar features, including cough and shortness of breath, however, each has different causes, treatment approaches, and outlooks.