FDA grants Breakthrough Therapy designation to Boehringer Ingelheim’s nintedanib

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy designation to nintedanib, an investigational therapy currently under FDA review for the treatment of people with idiopathic pulmonary fibrosis (IPF). The efficacy and safety of nintedanib in the treatment of IPF has not been established.

"Boehringer Ingelheim is proud that the FDA has granted Breakthrough Therapy designation for nintedanib, which will help expedite its development and review as a potential treatment option for patients with IPF," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs at Boehringer Ingelheim Pharmaceuticals, Inc. "We are committed to working with the FDA during the NDA review of nintedanib for people living with this serious and life-threatening lung disease, for which there are currently no FDA-approved treatment options."

The Breakthrough Therapy designation process was established by the FDA in 2012 and is intended to expedite the development and review of drugs for serious or life-threatening conditions, and preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

IPF is a serious and life-threatening lung disease that causes permanent scarring of the lungs, difficulty breathing and decreases the amount of oxygen the lungs can supply to the body. IPF affects as many as 132,000 Americans. There are currently no FDA-approved treatments.

Results from two global Phase 3 studies (INPULSIS™-1 and INPULSIS™-2) evaluating the efficacy and safety of nintedanib in the treatment of IPF were presented at the American Thoracic Society (ATS) International Conference and published in the New England Journal of Medicine in May 2014.

Nintedanib was granted Priority Review designation in June 2014, Fast Track designation in June 2013 and orphan drug status in June 2011.

Source: Boehringer Ingelheim Pharmaceuticals, Inc.