Roche Reports the US FDA's Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD
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
Click here to read the full press release
Tags
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com