The American Thoracic Society (ATS) now recommends that some patients with idiopathic pulmonary fibrosis (IPF) are eligible to be treated with Genentech’s Esbriet ® (pirfenidone). The conditional recommendation was based on three Phase 3 clinical trials of Esbriet vs. placebo in patients with IPF. In these studies, patients treated with Esbriet for 52 or 72 weeks experienced a lower all-cause mortality rate compared to patients who were treated with placebo.
“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,” according to material provided by Genentech.
Throughout these three Phase 3 clinical trials, 1,247 patients were evaluated, making this the largest clinical trial conducted in IPF so far. Regarding all-cause mortality, rates were significantly lower in Esbriet-treated patients than placebo-treated patients at 52 and 72 weeks, but there was no indication of a difference at 120 weeks. In terms of lung function, patients treated with Esbriet experienced a slower decline of lung function than did the placebo treated patients, and Esbriet even extended the length of time that individuals experienced no loss of lung function.
While these efficacy outcomes are exciting, Esbriet has also shown an excellent safety profile in treated patients. Esbriet is recommended for all stages of IPF, granted a patient’s healthcare provider and the patient believe Esbriet is the right treatment. If so, Genentech is willing to help patients pay for a prescription of Esbriet through the Access program developed by Genentech.
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.
- 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.
- Data on file.
- Esbriet Package Insert.
- Data on file.
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