FDA Approves Pair of Idiopathic Pulmonary Fibrosis Treatments

The FDA today approved pirfenidone (Esbriet) and nintedanib (Ofev) for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease that makes breathing difficult and causes irreversible lung damage.

According to the FDA, current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant. The agency previously granted Esbriet and Ofev fast track, priority review, orphan product, and breakthrough designations. Both drugs have been approved ahead of the dates on which the FDA was scheduled to complete the review of the 2 new drug applications.

Esbriet acts on multiple pathways that may be involved in the scarring of lung tissue. Its safety and effectiveness were established in 3 clinical trials of 1247 patients with IPF, which found the decline in forced vital capacity was significantly reduced in patients receiving Esbriet compared to those receiving placebo.

“Esbriet provides a new treatment option for patients with IPF, a serious, chronic lung disease,” said Curtis J. Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, in a press release. “We continue to help advance medication therapies by approving products that treat conditions that impact public health.”

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.

Similar to Esbriet, Ofev also blocks multiple pathways that may be involved in the scarring of lung tissue. Its safety and effectiveness were established in 3 clinical trials of 1231 patients with IPF, which found the decline in forced vital capacity was significantly reduced in patients receiving Ofev compared to those receiving placebo.

“Today’s Ofev approval expands the available treatment options for patients with IPF,” said Mary H. Parks, MD, deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, in a separate press release. “Providing health care professionals and patients with additional treatment options helps enable appropriate care decisions based on a patient’s need.”

Ofev is not recommended for patients who have moderate to severe liver problems. Ofev can cause birth defects or death to an unborn baby. Women should not become pregnant while taking Ofev. Women who are able to get pregnant should use adequate contraception during and for at least 3 months after the last dose of Ofev.

The most common side effects of Ofev are diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, decreased weight, and high blood pressure.

Esbriet is manufactured for InterMune Inc, and Ofev is distributed by Boehringer Ingelheim Pharmaceuticals Inc.