This article is more than 5 years old. Information may no longer be current.

FDA grants breakthrough therapy designation to Esbriet for unclassifiable ILD

The FDA has granted breakthrough therapy designation to pirfenidone for the treatment of adults with unclassifiable interstitial lung disease, according to a press release from Genentech.

The agency’s decision was based on phase 2 trial efficacy and safety results, which suggested that pirfenidone (Esbriet, Genentech) slowed disease progression and was successful in supporting lung function parameters such as FVC in patients with unclassifiable ILD. The safety and tolerability profile was also in line with that observed in phase 3 trials of the drug in patients with idiopathic pulmonary fibrosis. These data were reported at the European Respiratory Society International Congress and simultaneously published in The Lancet Respiratory Medicine in October 2019.

“Today’s milestone for Esbriet builds on our continued commitment to improving the standard of care for people living with fibrotic lung diseases,” Levi Garraway, MD, PhD, CMO of Genentech, said in the release. “We look forward to discussing the data with the FDA with the hope of bringing our important medicine to those with unclassifiable ILD who are currently without a treatment option.”

Pirfenidone is currently approved for the treatment of patients with IPF.