FDA Approves Esbriet to Treat Idiopathic Pulmonary Fibrosis

The U.S. FDA panel has approved a new drug, Esbriet, to treat people with idiopathic fibrosis, a fatal disease that is characterized by scarring of the lungs.

In a latest announcement, the U.S. Food and Drug Administration revealed that it had approved a new drug Esbriet (pirfenidone) to treat idiopathic pulmonary fibrosis. However, this new drug should not be used by those with severe liver problems, end-stage kidney disease or those who require dialysis.

The treatment is needed to be taken along with food to lower the chances of nausea and dizziness. Apart from this, patients should also avoid or lower their exposure to sunlight and sunlamps. The patients must wear protective clothing as well as sunscreen, as Esbriet may cause patients to get sunburnt very easily.

"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."

Idiopathic pulmonary fibrosis (IPF) is a chronic and fatal disease that is characterized by the progressive decline in lung function. It is a serious disease that affects middle-aged and older adults. This scarring of lungs causes the lungs to become stiff and makes it difficult to breathe. Over time, scarring gets so thick that the lungs fail to take in oxygen.

The treatment is being sanctioned much ahead of its product prescription drug user fee goal date of November 23, 2014, the date the agency was scheduled to complete the review of the drug application.

Esbriet is known to function in multiple pathways that may be involved in scarring of the lung tissue. The safety and effectiveness of the treatment was tested in three different clinical trials that involved 1,247 patients with IPF. The drop in forced vital capacity was drastically reduced in those receiving Esbriet as compared to those receiving placebo. Forced vital capacity is the amount of air that is forcibly exhaled from the lungs after taking deepest breath possible.

The common side effects reported included nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, reduced appetite, gastro-esophageal reflux disease, sinusitis, insomnia, lower weight and arthralgia (joint pain).

The FDA has simultaneously approved Ofev to treat IPF. The new treatment Esbriet is manufactured for InterMune, Inc.