Genentech’s Antifibrotic Oral Therapy Esbriet Receives FDA Priority Review for Unclassifiable Interstitial Lung Disease

Genentech, a member of the Roche Group, announced today that the U.S. FDA has accepted its supplemental New Drug Application (sNDA) for Esbriet (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). The FDA has also granted priority review to this application, with a decision expected by May 2021.

Interstitial Lung Disease (ILD) is a group of rare lung disorders encompassing more than 200 types. They share similar characteristics, including cough and shortness of breath. However, each type of ILD has distinct etiologies, treatments, and prognoses. Even after thorough evaluation, approximately one in ten patients with ILD remains undiagnosed; these cases are classified as unclassifiable interstitial lung disease (UILD).

Esbriet (pirfenidone) is an approved oral medication for the treatment of idiopathic pulmonary fibrosis (IPF). It exerts antifibrotic and anti-inflammatory effects by reducing the levels of various cytokines and decreasing the synthesis of matrix collagen. The drug has been marketed in more than 60 countries worldwide. In 2020, the U.S. Food and Drug Administration (FDA) granted Esbriet orphan drug designation and breakthrough therapy designation for the treatment of unclassifiable interstitial lung disease (UILD).

This sNDA is based on the results of a pivotal, 24-week Phase 2 clinical trial, which was the first randomized controlled study specifically designed and conducted exclusively in patients with UILD. The data have been published in The Lancet Respiratory Medicine. The trial results demonstrated that, at 24 weeks, the proportion of patients experiencing a decline in forced vital capacity (FVC) of ≥5% or ≥10% was significantly lower in the Esbriet group than in the placebo group.

“Since its approval, Esbriet has become the standard of care for patients with idiopathic pulmonary fibrosis. However, there remains a significant unmet need for patients with fibrosing interstitial lung diseases (ILDs), including uILD,” said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. “We are working closely with the FDA to make Esbriet available to patients with uILD as soon as possible.”

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a qualified healthcare provider at a reputable hospital.

References:

[1] FDA Grants Priority Review to Genentech’s Esbriet (pirfenidone) for Unclassifiable Interstitial Lung Disease. Retrieved January 21, 2021, from https://www.businesswire.com/news/home/20210120005802/en/

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