Roche Group subsidiary Genentech has received approval from US Food and Drug Administration (FDA) for Esbriet (pirfenidone) drug to treat patients with idiopathic pulmonary fibrosis (IPF).
Esbriet is an oral medicine believed to interfere with the production of transforming growth factor (TGF) beta, a small protein in the body involved in the growth of cells and tumor necrosis factor (TNF) alpha, a small protein involved in inflammation.
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Genentech chief medical officer Sandra Horning said: "This is a historic day for the people and their families in the United States who live with this deadly, incurable disease."
"With today’s approval of Esbriet in the US, people with IPF finally have an FDA-approved medicine that may slow the worsening of the disease."
Based on data from a placebo-controlled Phase III trial, Ascend, the approval is supported by two other Phase III trials, Capacity I and II.
More patients in the Ascend study who received Esbriet had a delay in the decline of lung function, compared against the placebo group.
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By GlobalDataEsbriet was developed for use by Roche’s recently acquired biotechnology company InterMune in the US, Europe and other countries.
InterMune research and development executive vice-president Jonathan Leff said: "Until today, the 100,000 people with IPF living in the US did not have an FDA-approved treatment."
At the start of this year, Esbriet received breakthrough therapy designation from FDA, based on the positive data from the Ascend clinical trial.
Image: Photomicrograph of the histopathological appearances of usual interstitial pneumonia in IPF. Photo: courtesy of IPFeditor.
