FDA approves Esbriet to treat idiopathic pulmonary fibrosis

For Immediate Release

October 15, 2014

Release

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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.