Genentech’s Esbriet (pirfenidone) Receives FDA’s Breakthrough Therapy Designation for 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