Esbriet (pirfenidone) by Genentech was recently included in the American Thoracic Society’s (ATS) updated idiopathic pulmonary fibrosis (IPF) treatment guidelines, which presents the drug’s proven benefits in delaying disease progression, as determined by the rate of lung function decline and patient mortality rates.

Esbriet’s final approval as a reliable treatment for IPF is based on the largest clinical research program for the disease to date, which included three Phase III trials and the participation of nearly 1,300 patients. In one of these trials, Esbriet was able to demonstrate a significant delay (48 percent) in lung function deterioration at year 1 of treatment, and more than twice the number of patients (2.3 times; 63 patients treated with Esbriet vs. 27 patients on placebo) showed no loss of function at all. These benefits and the drug’s safety have been proven in all stages of the disease, and its inclusion in the Society’s recently updated guidelines is a big step to making IPF a treatable condition.

It was only last October 2014 that Esbriet received FDA-approval as an IPF therapy. Prior to the approval, about 100,000 people in the US diagnosed with IPF were resigned to fighting an incurable disease with few treatment options. Since the FDA approval, over 10,000 people in the country have received Esbriet as a treatment for IPF.

To learn more about Genentech and Esbriet, visit Genentech-Access.com.

Esbriet Indication

Esbriet is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).

Important Safety Information For Esbriet

Before taking Esbriet, patients should tell their doctor if they:

• have liver problems
• have kidney problems
• are a smoker
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Esbriet will harm the unborn baby.

• are breastfeeding or plan to breastfeed. It is not known if Esbriet passes into breast milk. Patients and their doctor should decide if they will take Esbriet or breastfeed.

Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Patients should avoid:

• Sunlight. Esbriet can make skin sensitive to the sun and the light from sunlamps and tanning beds. Patients could get a severe sunburn. Patients must use sunscreen (SPF50) and wear a hat and clothes that cover the skin if they have to be in sunlight. Patients should talk to their doctor if they get a sunburn.
• Smoking. Smoking may affect how well Esbriet works.

Esbriet may cause serious side effects, including:

• Liver problems: Patients must call their doctor right away if they have unexplained symptoms such as yellowing of their skin or the white part of their eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of their stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired. The doctor will do blood tests to check how a patient’s liver is working during treatment with Esbriet.
• Sensitivity to sunlight (photosensitivity) and rash.
• Stomach problems.Esbriet may cause stomach problems such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain. Patients must tell their doctor right away if their stomach problems get worse or do not go away. The doctor may need to change the patient’s dose of Esbriet.

The most common side effects of Esbriet include feeling tired, headache, dizziness and decreased or loss of appetite.

These are not all the possible side effects of Esbriet. For more information, patients should ask their doctor or pharmacist.

You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to InterMune at (888) 486-6411.

Please visit http://www.Esbriet.com for the full Prescribing Information including Patient

Information for additional important safety information.

Footnotes

*Esbriet received a conditional recommendation. This means that clinicians are encouraged to discuss preferences with their patients when making treatment decisions.

**In an all-cause mortality exploratory analysis from three Phase III trials, there was no statistically significant difference between Esbriet and placebo over the study and follow-up period (up to 120 weeks for available patients).³  At 52 weeks, all-cause mortality was 3.6 percent with Esbriet vs 6.8 percent for placebo; and at 72 weeks, all-cause mortality was 6.6 percent with Esbriet vs 9.6 percent for placebo, with no statistically significant difference at 120 weeks.⁴

References

1. King TE Jr, Bradford WZ, Castro-Bernardini S, et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med.
2. Data on file.
3. Esbriet Package Insert.
4. Data on file.

About Genentech

Founded more than 35 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com