FDA 'Breakthrough' status for Roche's Esbriet in unclassifiable ILD

The US Food and Drug Administration 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 randomized controlled trial to exclusively enroll patients with progressive fibrosing uILD, said the drug’s sponsor, Roche (ROG: SIX), whose shares were up more than 3% at 319.40 Swiss France by early afternoon trading.

Already a blockbuster drug