FDA grants breakthrough therapy designation for Genentech’s Esbriet (pirfenidone) in unclassifiable interstitial lung disease


2 March 2020 - There are currently no FDA approved treatments for unclassifiable ILD, a debilitating, severe respiratory condition.

Genentech today announced that the U.S. FDA has granted breakthrough therapy designation to Esbriet (pirfenidone) for adults with unclassifiable interstitial lung disease (uILD). 

The designation was granted based on data from a Phase II trial, which studied the efficacy and safety of Esbriet in uILD. The study represented the first randomised controlled trial to exclusively enrol patients with progressive fibrosing uILD.

Read Genentech press release

Michael Wonder

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Michael Wonder