Esbriet is an oral medication intended to treat people with idiopathic pulmonary fibrosis and is available in more than 60 countries around the world
FDA grants breakthrough therapy designation for Genentech’s Esbriet (Credit: F. Hoffmann-La Roche Ltd.)
Roche subsidiary Genentech has obtained the US Food and Drug Administration (FDA) breakthrough therapy designation for its Esbriet (pirfenidone) to treat unclassifiable interstitial lung disease (uILD) in adult patients.
ILD refers to a diverse group of more than 200 types of rare pulmonary diseases, characterised by similar features, including cough and shortness of breath. ILD has different causes, treatment approaches and outlooks.
Esbriet is an oral medication intended to treat people with idiopathic pulmonary fibrosis (IPF) and is available in more than 60 countries around the world. The drug was approved in Europe in 2011 and in the US in October 2014 to treat adults with IPF.
Roche global product development head and chief medical officer Levi Garraway said: “Today’s milestone for Esbriet builds on our continued commitment to improving the standard of care for people living with fibrotic lung diseases.
“We look forward to discussing the data with the FDA with the hope of bringing our important medicine to those with uILD who are currently without a treatment option.”
FDA granted designation based on data from a Phase 2 clinical trial of Esbriet
The healthcare technology firm said that the FDA breakthrough therapy designation was granted based on data from a Phase 2 clinical trial, which evaluated the efficacy and safety of Esbriet in uILD, in patients with progressive fibrosing uILD.
The primary endpoint of the trial includes mean predicted change in FVC from baseline over 24 weeks, measured by daily home spirometry.
The secondary endpoints include the change in FVC measured by site spirometry, the proportion of patients who had a more than 5% or more than 10% decline in predicted FVC measured by clinic-based spirometry, changes in predicted DLco, and change in 6-min walk distance (6MWD).
In addition, the secondary endpoint includes University of California San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) score, Leicester Cough Questionnaire score, cough visual analogue scale, and the St. George’s Respiratory Questionnaire (SGRQ), compared with baseline.
The data from Phase 2 trial demonstrated that Esbriet would prevent the disease progression and its efficacy supports various lung functions parameters including forced vital capacity (FVC), in people with uILD.
The safety and tolerability profile of Esbriet in uILD patients is said to be comparable with that observed in Phase 3 trials in idiopathic pulmonary fibrosis (IPF) patients.