During the 2015 American Thoracic Society Conference (ATS), Genentech presented new data on Esbriet (pirfenidone) — one of the first medicines approved by the US Food and Drug Administration to treat idiopathic pulmonary fibrosis (IPF), a serious disease of unknown origins that causes permanent scarring of the lungs.
Esbriet, a breakthrough drug developed by California-based InterMune, Inc. is able to treat fibrosis, limit resulting decline in lung function in IPF patients, and help restore quality of life.
All three of Esbriet’s clinical trials involving 1,247 IPF patients showed impressive safety, tolerance, and efficacy as measured by significantly reduced loss of lung function by nearly 50% of participants, and decline in the 6-minute walk distance (6MWD) test by 27.5%. When data from several studies were gathered and cross-examined, the drug was noted to reduce all-cause mortality by 48% compared to those who were on a placebo.
Specifically, the results presented during the 2015 ATS meeting revealed that:
- Continued treatment with Esbriet following an initial worsening of IPF during the first six months of treatment reduced the risk of a decline in lung function or death during the next six months;
- The impact of treatment with Esbriet is comparable in earlier versus later disease, supporting the initiation of treatment soon after IPF diagnosis when pulmonary function is still relatively preserved;
- A comprehensive analysis of safety outcomes from five clinical trials showed that long-term treatment with Esbriet did not reveal any new or unexpected side effects.
The drug should be prescribed cautiously if patients have liver or kidney problems, are smokers, have any other medical conditions, are pregnant or plan to become pregnant. It is not known if Esbriet will harm the unborn baby. For women who are breastfeeding or plan to breastfeed, it is also not known if Esbriet passes into breast milk. Patients and their doctor should decide if they will take Esbriet or breastfeed.
While under treatment with the drug, patients should avoid sunlight and smoking.
In terms of Select Important Safety Information, Esbriet may cause serious side effects, such as liver problems, sensitivity to sunlight (photosensitivity), rash and stomach problems such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain. Other common side effects of Esbriet include feeling tired, headache, dizziness and decreased or loss of appetite.