Two FDA drug approvals for idiopathic pulmonary fibrosis (IPF)

By: Badrul A. Chowdhury, M.D., Ph.D.

Badrul ChowdhuryPulmonary 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.

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 our 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. We are addressing the input received from our 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.

Badrul A. Chowdhury, M.D., Ph.D., is Director, Division of Pulmonary, Allergy, and Rheumatology Products in FDA’s Center for Drug Evaluation and Research

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