FDA approved two drugs for idiopathic pulmonary fibrosis (IPF)

Last Updated on October 23, 2014 by Joseph Gut – thasso

October 23, 3014 – Pulmonary fibrosis is a disease in which tissue deep inside the lungs becomes thick, stiff, and scarred, decreasing the lungs’ ability to expand to take in air, and making it difficult to breathe. This is a progressive disease in which scarring and lack of elasticity in the lungs continues to increase until the patient can no longer breathe enough to sustain life.

Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis (IPF)

Until recently, patients in the U.S. suffering from idiopathic pulmonary fibrosis (IPF), a form of pulmonary fibrosis in which the cause is unknown, had no drug treatment  approved by FDA for this debilitating, incurable, and terminal condition. However, this month, FDA approved Ofev (nintedanib) and Esbriet (pirfenidone), two important new therapies for the treatment of patients with IPF. Both drugs are “first-in-class” products that offer new hope for patients in the U.S. with IPF.

Researchers don’t understand exactly how Ofev and Esbriet work in the body against IPF, but the drugs seem to inhibit important pathways that help to prevent scarring. Neither drug is a cure. IPF may still progress after patients use these drugs. However, each drug has been shown to significantly slow the progression of the disease.

There is much work to be done, but this is a valuable start. In continuing efforts to advance drug development for IPF, FDA recently hosted a Public Meeting on Idiopathic Pulmonary Fibrosis Patient-Focused Drug Development to obtain patients’ input on the impact of IPF on their daily life and their views on currently available therapies to treat the condition. Many patients in the U.S. with IPF will now have effective treatments for their condition. FDA is addressing the input received from the public meeting on IPF and will continue to support the development and approval of new drugs, especially those that help patients with serious or life-threatening conditions for which no drug treatments are available.

This is a  commentary by FDA’s Badrul A. Chowdhury, M.D., Ph.D., which in essence can be found here.

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Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.