FDA accepts Esbriet for priority review as UILD therapy

The US Food and Drug Administration has accepted the supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD).

The FDA is expected to make a decision on approval by May 2021, says the drug’s developer, Swiss pharma giant Roche (ROG: SIX).

“Since its US approval, Esbriet has become a standard of care for people living with idiopathic pulmonary fibrosis. However, significant unmet need remains in fibrotic lung diseases, including unclassifiable interstitial lung disease (UILD),” said Dr Levi Garraway, Roche’s chief medical officer and head of global product development. “We are working closely with the FDA in hopes of offering Esbriet to people with UILD, a rare and debilitating disease,” he added.

Clinical backing