Genentech Statement On Updated ATS Guidelines

Esbriet Is Recommended In The American Thoracic Society’s (ATS) Idiopathic Pulmonary Fibrosis (IPF) Treatment Guidelines

  • New clinical practice guidelines recommend Esbriet® (pirfenidone) for treatment of IPF
  • Guidelines positively discuss Esbriet data on patient-important outcomes such as delaying disease progression as measured by rate of lung function decline and mortality

Genentech is encouraged that Esbriet (pirfenidone) is now recommended in the new American Thoracic Society’s (ATS) idiopathic pulmonary fibrosis (IPF) treatment guidelines.* The guidelines are good news for IPF patients, and positively discuss existing data for Esbriet on patient-important outcomes of delaying disease progression as measured by the rate of lung function decline and mortality.**

Esbriet was approved for the treatment of IPF on the basis of the largest clinical trial program in IPF to date, including three Phase III trials with a total of 1,247 patients. In one clinical study, after one year of treatment, Esbriet slowed the loss of lung function by about half (48 percent)1 and more than doubled (2.3 times; 63 patients treated with Esbriet vs. 27 patients on placebo) the number of people who did not lose any lung function.1 Esbriet’s efficacy and safety have been evaluated in IPF patients with earlier as well as more advanced disease and Esbriet is indicated across all stages of IPF. The approval of Esbriet for IPF may help change the course of disease and inclusion in the ATS guidelines reinforces that this serious disease may now be a treatable one.

Until last October, there were no FDA-approved medicines for the approximately 100,000 people in the U.S. living with this irreversible and progressive lung disease. More than 10,000 people in the U.S. have since been treated with Esbriet. Esbriet has extensive real-world experience, including more than 15,000 patient-years in Europe, where it has been approved since 2011.2

Genentech is committed to helping people access Esbriet once it has been prescribed, regardless of their ability to pay. The company’s Access Solutions program offers support throughout the course of treatment and provides free medicine to eligible people who do not have insurance, are underinsured or rendered uninsured due to payer denial, and providing co-pay assistance to those who qualify.

Genentech is dedicated to working with ATS and the medical community to help improve IPF management and to offer hope for people affected by this disease.

For more information on the ATS guidelines, visit http://www.thoracic.org/statements/resources/interstitial-lung-disease/IPF-Full-length.pdf .

For more information on Access Solutions, visit Genentech-Access.com.

ESBRIET INDICATION

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

ESBRIET IMPORTANT SAFETY INFORMATION

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 40 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.