Shots:

• The sNDA submission is based on a P-II study that involves assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing UILD for 24wks. The anticipated PDUFA date is May’2021
• Results: Over 24wks. predicted median change in FVC measured by home spirometry (-87.7 vs -157.1 mL); change in percent predicted DLco and 6MWD are in favor of Esbriet. Additionally- less loss to lung function and exercise capacity was observed
• Esbriet is an oral therapy for IPF and is available in more than 60+ countries globally. FDA has granted ODD and BTD to the therapy in 2020

 ­ Ref: Roche | Image: Roche