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FDA Approves 2 New Drugs for Idiopathic Pulmonary Fibrosis

The FDA has approved 2 new drugs for the treatment of idiopathic pulmonary fibrosis (IPF).

Pirfenidone (Esbriet, InterMune, Inc) works by acting on multiple pathways involved in the process of lung scarring in IPF.1

Its safety and efficacy were tested in 3 clinical trials of 1247 participants with IPF. Those patients taking pirfenidone showed significantly decreased decline in vital capacity—the amount of air able to be forcibly exhaled after taking a deep breath—than in controls.
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Pirfenidone is not recommended for patients with severe liver problems, kidney disease, or those patients on dialysis. Common side effects include susceptibility to sunburn, nausea, abdominal pain, rash, fatigue, headache, dizziness, and sinusitis.

Nintedanib (Ofev, Boehringer Ingelheim Pharmaceuticals, Inc) is a kinase inhibitor that blocks pathways involved in the scarring process in IPF.2

In 3 clinical trials of 1231 participants, nintedanib significantly reduced the decline in vital capacity compared to placebo.

The FDA warns that nintedanib may cause birth defects or death in unborn babies, and therefore, is not recommended for pregnant women.

The most common side effects are diarrhea, nausea, vomiting, liver enzyme elevation, and high blood pressure.

Both drugs were granted fast track, priority review, and approved before their originally intended approval dates.

—Michael Potts

References:

  1. FDA. FDA approves Esbriet to treat idiopathic pulmonary fibrosis [press release]. October 15, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418991.htm. Accessed October 17, 2014.
  2. FDA. FDA approves Ofev to treat idiopathic pulmonary fibrosis [press release]. October 15, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418994.htm. Accessed October 17, 2014.