FDA Approves Two Medications for Idiopathic Pulmonary Fibrosis

Ofev and Esbriet both approved to treat idiopathic pulmonary fibrosis

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Until Wednesday, people with idiopathic pulmonary fibrosis (IPF) had limited treatment options. Treatment options for this chronic lung condition expanded when the US Food and Drug Administration (FDA) approved two separate medications to treat IPF.

The FDA approved Ofev (nintedanib) and Esbriet (pirfenidone) to treat IPF.

The medications treat IPF in different ways, but both appeared safe and effective in clinical trials.

IPF is a chronic disease that causes the lungs to become scarred over time. This scarring can cause patients to have trouble breathing, which can limit their ability to complete daily tasks.

Before Wednesday's approvals, treatments for IPF included oxygen therapy, lung rehabilitation and lung transplant, reports the FDA.

Ofev was studied in three trials of 1,231 patients in total. In these studies, patients who received Ofev — rather than a placebo, or fake pill — saw an increase in lung capacity.

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

Esbriet also proved effective in trials — it was tested on 1,247 patients over three trials. The patients who received the active pill saw greater increases in lung capacity than those who received a placebo.

Neither medication is recommended for patients with liver problems.

Patients should not become pregnant while taking Ofev, the FDA warns. Patients taking Esbriet should avoid too much sun exposure and wear protective clothing and sunscreen. Esbriet may cause patients to sunburn easily, the FDA notes.

The two treatments shared some common side effects: nausea, diarrhea, headache, loss of appetite and decreased weight. Another common side effect of Ofev was increased liver enzymes. Esbriet carried a risk of respiratory infections.

Intermune Inc. markets Esbriet. Boehringer Ingelheim Pharmaceuticals markets Ofev.

Review Date: 
October 15, 2014
Last Updated:
October 20, 2014