Roche's Antifibrotic Oral Therapy Esbriet Receives FDA Breakthrough Therapy Designation for Unclassifiable Interstitial Lung Disease

Recently, Genentech, a member of the Roche Group, announced that the U.S. FDA has granted Breakthrough Therapy Designation to Esbriet (pirfenidone) for the treatment of adult patients with unclassifiable interstitial lung disease (uILD).

Interstitial Lung Disease (ILD) is a group of disorders that affect the lung interstitium. These patients may present with a progressive phenotype, leading to pulmonary fibrosis, decline in lung function, deterioration in quality of life, and premature death. Although the symptoms and disease progression are similar, ILD has many different causes. The press release noted that approximately 10% of ILD patients do not receive a definitive diagnosis; these patients are classified as having unclassifiable interstitial lung disease (uILD). Currently, there are no FDA-approved therapies for this condition.

Esbriet (pirfenidone) is an oral medication approved for the treatment of idiopathic pulmonary fibrosis (IPF), with antifibrotic and anti-inflammatory effects. It has been marketed in more than 60 countries worldwide. Esbriet was approved in Europe in 2011 for the treatment of adult patients with mild to moderate IPF, and in October 2014, it was approved in the United States for the treatment of patients with IPF.

▲Molecular structure of pirfenidone (Image source: Fuse809 / Public domain)

This breakthrough therapy designation is based on the positive results of Esbriet in a Phase 2 clinical trial. The study was the first randomized controlled trial to include patients with unclassifiable interstitial lung disease (ILD) featuring progressive fibrosis. Trial data demonstrated that treatment with Esbriet delayed disease progression by 24 weeks in these patients and improved multiple pulmonary function parameters, including forced vital capacity (FVC).

“Esbriet’s receipt of Breakthrough Therapy Designation from the FDA represents our ongoing commitment to improving the standard of care for patients with fibrotic lung diseases,” said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. “We look forward to continuing our collaboration with the FDA, with the aim of bringing our blockbuster medication to patients with uILD who currently lack effective treatment options.”

References:

[1] FDA Grants Breakthrough Therapy Designation for Genentech’s Esbriet (pirfenidone) in Unclassifiable Interstitial Lung Disease, Retrieved March 03, 2020, from https://www.gene.com/media/press-releases/14840/2020-03-02/fda-grants-breakthrough-therapy-designat

Headline: Flash | Roche’s Oral Anti-Fibrotic Therapy Receives FDA Breakthrough Therapy Designation for Treating Patients with Specific Lung Diseases

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