FDA Approves Ofev and Esbriet for Idiopathic Pulmonary Fibrosis

Larry Hand


October 15, 2014

The US Food and Drug Administration (FDA) has approved for marketing nintedanib (Ofev, Boehringer Ingelheim) and pirfenidone (Esbriet, InterMune) for patients with idiopathic pulmonary fibrosis (IPF).

Individuals with IPF have progressively scarred lungs over time and experience shortness of breath, cough, and difficulty participating in normal daily activities.

Prior to these approvals, treatments for IPF included oxygen therapy, pulmonary rehabilitation, and lung transplantation.

Nintedanib and pirfenidone were granted approval through a triple-path process: fast track, orphan product, and breakthrough designations. The approvals today come ahead of pirfenidone's and nintedanib's expected approval dates of November 23, 2014, and January 2, 2015, respectively.

"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 Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research. "Providing health care professionals and patients with additional treatment options helps enable appropriate care decisions based on a patient's need."

A kinase inhibitor, nintedanib blocks multiple pathways involved in lung-scarring tissue. Researchers established its safety in three clinical trials of 1231 patients with IPF. In terms of efficacy, patients experienced significantly reduced declines in force vital capacity, or the amount of air that can be forcibly exhaled after a deep breath, compared with patients who received placebo.

However, nintedanib is not recommended for patients with moderate-to-severe liver problems. Nintedanib also carries the possibility of adverse effects, including birth defects or stillbirth, so women should not become pregnant while taking it.

Most often, adverse effects include diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite and weight, and hypertension.

Espriet also acts on multiple pathways, and researchers established its safety profile in three clinical trials involving 1247 patients with IPF.

It too is not recommended for patients with liver problems or end-stage kidney disease, or who require dialysis. It should be taken with food, and patients should avoid sunlight or sunlamp exposure.

It has similar adverse effects.


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