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news.Genentech, Roche's subsidiary, has received approval from US Food and Drug Administration (FDA) for Esbriet (pirfenidone) to treat patients with idiopathic pulmonary fibrosis (IPF).
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Esbriet is an oral medicine and is 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.
Genentech chief medical officer Sandra Horning said with the approval of Esbriet in the US, people with IPF finally have an FDA-approved medicine that may slow the worsening of the disease.
"This is a historic day for the people and their families in the United States who live with this deadly, incurable disease," Horning said.
The approval is based on data from a placebo-controlled Phase III trial called Ascend as well as it is supported by two other Phase III trials Capacity I and II.
Patients in the Ascend trial who received Esbriet had a delay in the decline of lung function, compared against the placebo group.
Esbriet was developed for use by Roche’s recently acquired biotechnology company InterMune in the US, Europe and other countries.