Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

 Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

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

Click here ­to­ read full press release/ article | Ref: Roche| Image: The Indian Express

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