FDA approves two new drugs to treat IPF

SILVER SPRING, Md. — The Food and Drug Administration has granted approval to Esbriet (pirfenidone), as well as Ofev (nintedanib), to treat idiopathic pulmonary fibrosis — a condition in which the lungs scar over time. As a result of the scarring, patients with IPF experience shortness of breath, cough and have trouble taking part in physical activities. 

 

“Esbriet provides a new treatment option for patients with idiopathic pulmonary fibrosis, a serious, chronic lung disease,” said Curtis J. Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

 

Mary H. Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, added that Ofev's approval will provide "healthcare professionals and patients with additional treatment options that helps enable appropriate care decisions based on a patient’s need.”

 

Current treatment options for those suffering with the condition include oxygen therapy, pulmonary rehabilitation and lung transplant, according to the agency. The FDA granted both of the drugs fast-track, priority review, orphan product and breakthrough designations. Esbriet and Ofev work by blocking multiple pathways that may be involved in the scarring of lung tissue, according to the agency.

 

Esbriet is distributed by InterMune and Ofev is distributed by Boehringer Ingelheim Pharmaceuticals.