NINTEDANIB AND PIRFENIDONE GRANTED BREAKTHROUGH THERAPY DESIGNATION

Jul 17, 2014, 17:45 PM
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PFF Comment
Gregory P. Cosgrove, MD, Chief Medical Officer

"The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for nintedanib (Boehringer Ingelheim) and pirfenidone (InterMune, Inc.), two promising therapies for patients with idiopathic pulmonary fibrosis (IPF).  This is a significant step forward in the FDA’s review process for these agents and reflects the serious and life-threatening nature of IPF and evidence from the INPULSIS 1 & 2* and ASCEND* trials suggesting substantial treatment effects, especially as there are not any available therapies for the disease.1,2  The expedited review by the FDA that is associated with a Breakthrough Therapy Designation highlights the recognized importance of identifying a therapy for this devastating disease."

References


1    Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med 2014; 370:2071-2082

2    King TE, Jr., Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, Gorina E, Hopkins PM, Kardatzke D, Lancaster L, Lederer DJ, Nathan SD, Pereira CA, Sahn SA, Sussman R, Swigris JJ, Noble PW. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med 2014; 370:2083-2092


View Boehringer Ingelheim Press Release

View InterMune Press Release
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