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Is Esbriet an Approved Treatment for IPF?

Genentech’s Esbriet (pirfenidone) was approved by the US Food and Drug Administration (FDA) in 2014 to treat idiopathic pulmonary fibrosis (IPF), a fatal disease characterized by progressive scarring (fibrosis) of lung tissue. This is great news for people with IPF, as prior to the development of Esbriet and nintedanib (Ofev), another new drug approved to treat IPF, there were no medications known to slow the progressive nature of IPF. In fact, most people lived only 3 to 5 years after diagnosis.[1]

Brief Overview of IPF

esbriet, ipf, idiopathic pulmonary fibrosisIPF is a form of interstitial lung disease, a term that refers to a broad range of progressive lung diseases in which inflammation and scarring of the lung tissue play a starring role in their development.[2]

According to the American Lung Association, there are more than 50,000 new cases of IPF diagnosed each year.[3]

The most common symptoms of IPF include shortness of breath that worsens over time and a dry, hacking cough that doesn’t seem to go away. Repeated bouts of uncontrolled coughing are also common. Other symptoms include:[4]

  • Rapid, shallow breathing
  • Unintended, gradual weight loss
  • Fatigue (feeling tired) and malaise (feeling unwell)
  • Sore, aching muscles and joints
  • Clubbing (rounding of the fingertips) due to lack of oxygen

How Does Esbriet Work?

IPF progressively destroys lung function. When lung function is lost, it cannot be restored. However, Esbriet may help preserve your lung function by slowing disease progression.[5]

The way pirfenidone (the active substance in Esbriet) works is not fully understood; however, the drug has been shown to decrease the production of fibroblasts and other substances involved in the formation of scar tissue during the body’s own healing process, thereby slowing the progression of the disease.[6]

What Does the Research Say?

Esbriet has been used in more than 31,000 patients worldwide. The drug company Genetech conducted three, phase 3 clinical trials to evaluate the safety and efficacy of Esbriet and the results were reviewed by the FDA.5

In each clinical trial, the effect of Esbriet on how well the lungs work was measured by forced vital capacity (FVC), a measurement taken during a spirometry test that represents the amount of air you can forcibly exhale after taking the deepest breath possible.5

Each study was composed of 1,247 participants with IPF. Here are the results of those studies:5

  • At the end of a 1-year clinical study of people with IPF, more than twice (23%) as many participants had stable lung function compared to 10% of those who were given a placebo.
  • One 72-week clinical trial showed similar results as shown above.
  • Another 72-week clinical trial did not show a significant difference between those who took Esbriet and those who did not.

In addition, Esbriet was found to improve breathing capacity as measured by an increase in FVC. Here are the results of this part of the same study:5

  • In a 1-year clinical study, people who took Esbriet demonstrated an improvement in breathing capacity, e.g. less decline in FVC, comparted to those who were given a placebo. In fact, there was a 193 ml difference between the two study groups.
  • One 72-week study showed similar results as shown above.
  • Another 72-week study showed no significant difference between those who took Esbriet and those who did not.

Have you tried Esbriet? Let us know how it’s working for you in the comments below.

For more information about treating IPF with Esbriet, or if you’re wondering if this drug may be right for you, contact your pulmonologist or primary care provider.

[1] Stewart, Janet. MSc, PhD. Researchers Review Performance of Genentech’s Esbriet in Treating Idiopathic Pulmonary Fibrosis. Lung Disease News. April 11, 2017.
[2]  Mayo Clinic. Interstitial Lung Disease. Updated 6/11/2015.

[3] American Lung Association. Types, Causes and Risk Factors of Pulmonary Fibrosis. Last reviewed January 17, 2018.

[4] National Heart, Lung and Blood Institute. Idiopathic Pulmonary Fibrosis. Accessed March 31, 2018.

[5] Genetech. Esbriet. Accessed March 31, 2018.

[6] European Medicines Agency. Espriet (pirfenidone). Updated November 1, 2018.

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