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By Amy Orciari Herman
Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
The FDA has granted fast-track approval for two new oral therapies for idiopathic pulmonary fibrosis, the agency announced on Wednesday.
Pirfenidone (brand name, Esbriet) acts on multiple pathways that may be involved in the scarring of lung tissue, according to the FDA. Nintedanib (brand name, Ofev) is a kinase inhibitor that also helps inhibit such scarring. In patients taking either drug in clinical trials, the decline in forced vital capacity was reduced, compared with those on placebo.
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LINK(S):
FDA news release on pirfenidone (Free)
FDA news release on nintedanib (Free)
Background: NEJM Journal Watch General Medicine coverage of pirfenidone and nintedanib trials (Your NEJM Journal Watch subscription required)