FDA Approves Esbriet
FDA Approves Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis
October 15, 2014 -- The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).
Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.
“Esbriet provides a new treatment option for patients with idiopathic pulmonary fibrosis, a serious, chronic lung disease,” said Curtis J. Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “We continue to help advance medication therapies by approving products that treat conditions that impact public health.”
The FDA granted Esbriet fast track, priority review, orphan product, and breakthrough designations. Esbriet is being approved ahead of the product’s prescription drug user fee goal date of Nov. 23, 2014, the date the agency was scheduled to complete the review of the drug application.
Esbriet acts on multiple pathways that may be involved in the scarring of lung tissue. Its safety and effectiveness were established in three clinical trials of 1,247 patients with IPF. The decline in forced vital capacity – the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible – was significantly reduced in patients receiving Esbriet compared to patients receiving placebo.
Esbriet is not recommended for patients who have severe liver problems, end-stage kidney disease, or who require dialysis. Esbriet should be taken with food to minimize the potential for nausea and dizziness. Patients should avoid or minimize exposure to sunlight and sunlamps and wear sunscreen and protective clothing, as Esbriet may cause patients to sunburn more easily.
The most common side effects of Esbriet are nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, decreased/loss of appetite, gastro-esophageal reflux disease, sinusitis, insomnia, decreased weight, and arthralgia.
The FDA also today approved Ofev (nintedanib) for the treatment of IPF.
Esbriet is manufactured for InterMune, Inc., Brisbane, California.
Posted: October 2014
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- InterMune Receives FDA Breakthrough Therapy Designation for Pirfenidone, an Investigational Treatment for IPF - July 17, 2014
- InterMune Announces Resubmission Of NDA For Pirfenidone For The Treatment Of Patients With IPF - May 27, 2014
- InterMune Announces Expanded Access Program for Pirfenidone to Treat Idiopathic Pulmonary Fibrosis (IPF) in the United States - May 16, 2014
- InterMune Reports Phase 3 ASCEND Trial Results of Pirfenidone in Idiopathic Pulmonary Fibrosis (IPF) - February 25, 2014
- Coalition for Pulmonary Fibrosis Responds to News of Further Review of Pirfenidone By FDA - May 7, 2010
- InterMune Receives FDA Complete Response Letter on Esbriet (pirfenidone) New Drug Application - May 5, 2010
- FDA Advisory Committee Recommends Approval of InterMune's Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis - March 10, 2010
- InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone - March 5, 2010
- FDA Grants Priority Review of Pirfenidone NDA for the Treatment of Patients With IPF - January 6, 2010
- InterMune Announces Submission of NDA for Pirfenidone for the Treatment of Patients with IPF - November 4, 2009
Esbriet (pirfenidone) FDA Approval History
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