Genentech’s ESBRIET Recommended in ATS Guidelines for IPF Treatment

Genentech recently announced in a statement that Esbriet (pirfenidone) has been recommended in the new American Thoracic Society’s (ATS) idiopathic pulmonary fibrosis (IPF) treatment guidelines. This recommendation, which is published as a resource for clinicians, is conditional and the ATS notes that healthcare providers should always discuss the pros and cons of treatment options with their patients before prescribing a therapy such as Esbriet.

FDA approval of Esbriet in the Fall of 2014 brought much-needed therapeutic options to those who suffer from IPF, which has no cure and is estimated to affect almost 130,000 people in the United States and 5 million people worldwide. It is a progressive, fatal lung disease of unknown origin in which the alveoli and the lung tissue suffer permanent scarring (fibrosis), leading to severe breathing difficulties and compromising oxygen transfer between the lungs and the bloodstream. Patients with IPF experience a shortness of breath that gradually worsens over time, with respiratory failure being the main cause of death associated with the disease. IPF has a poor prognosis and around two-thirds of patients succumb to the disease within five years after being diagnosed. An early diagnosis and proper treatment are crucial to maximizing survival and quality of life.

Esbriet (pirfenidone) is an oral therapy that was developed for the treatment of pulmonary fibrosis. It is an anti-fibrotic drug that is thought to work by decreasing the production of collagen and growth and inflammatory factors, ultimately leading to a reduction in lung fibrosis. Esbriet has been shown in different Phase III clinical trials to slow the decline of lung function in IPF patients and consequently disease progression.

In October 2014, the U.S. Food and Drug Administration (FDA) approved Esbriet for IPF treatment, and along with Ofev was among the first IPF drugs to receive approval in the United States. To date, more than 10,000 people with IPF have been prescribed Esbriet, and Genentech believes that the approval of the drug as an IPF treatment may help change the disease’s course. Now, with its inclusion in the ATS guidelines, the company sees this as an endorsement that IPF is a treatable disease.

Esbriet’s 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.

Visit Esbriet.com for the full prescribing information.