Genentech’s Esbriet (pirfenidone) Receives FDA’s Breakthrough Therapy Designation for Unclassifiable Interstitial Lung Disease

 Genentech’s Esbriet (pirfenidone) Receives FDA’s Breakthrough Therapy Designation for Unclassifiable Interstitial Lung Disease

Genentech, Esbriet, pirfenidone, Receives, FDA, Breakthrough Therapy Designation, Unclassifiable, Interstitial Lung Disease

Shots:

  • The US FDA’s BT designation is based on P-II study assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing uILD, an FVC of ≥45%, DLco of ≥30%, >10% fibrosis on high-resolution CT and a high-resolution CT from the previous 12mos.
  • The P-II study results: slowed disease progression; predicted median change in FVC measured by home spirometry (-87.7 vs -157.1 ml) @24wks.; DLco and 6MWD trended in favor of Esbriet; safety & tolerability profile is comparable with P-III studies in IPF
  • Esbriet is an oral therapy, indicated to treat IPF and has received EMA & the FDA’s approval for the treatment of mild to moderate IPF in 2011 & 2014 respectively

Click here ­to­ read full press release/ article | Ref: Genentech | Image: Nature

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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