Genentech Announces FDA Approval of Idiopathic Pulmonary Fibrosis Treatment

Genetech announced on Oct. 15, 2014 that it received FDA approval for Esbriet, or pirfenidone, as a treatment for the fatal lung disease Idiopathic Pulmonary Fibrosis (IPF). Esbriet was developed by InterMune, a subsidiary of Roche. According to the National Institutes of Health (NIH), IPF is a disease that causes tissue in the lungs to become scarred over time, limiting oxygen into the bloodstream. There is no cure, causing many patients to live only three to five years after diagnoses, experiencing respiratory failure, pulmonary hypertension, heart failure, pulmonary embolism, pneumonia, or lung cancer.

The approval of Esbriet is based on a large, placebo-controlled Phase III study, ASCEND, as well as two other Phase III trials, CAPACITY 1 and 2. The ASCEND study resulted in more patients experiencing a delay in the decline of lung function compared to those receiving a placebo. Esbriet is an oral medication that is believed to interfere with the production of transforming growth factor-beta, which is a protein involved in how cells grow, and tumor necrosis factor-alpha, which is a protein involved in inflammation. Esbriet will be available to patients within two weeks.

Also approved for the treatment of IPF is Boehringer Ingelheim’s tyrosine kinase inhibitor, OFEV.