Boehringer Ingelheim announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Ofev® (nintedanib), which is currently under FDA review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Regulatory applications have been submitted to other regulatory bodies, including the European Medicines Agency.
The Breakthrough Therapy Designation was supported by results from the Phase III INBUILD® study – the first clinical trial of these ILDs that met its primary endpoint and showed nintedanib slowed the rate of ILD progression in patients with a broad range of progressive fibrosing interstitial lung diseases other than idiopathic pulmonary fibrosis (IPF). The results were recently presented at the European Respiratory Society (ERS) International Congress in Madrid and published in the New England Journal of Medicine.
Interstitial lung diseases encompass a large group of more than 200 disorders that may lead to pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function. When a progressive phenotype is present, a life-threatening condition can result that causes difficulty breathing and a decrease in the amount of oxygen the lungs can supply to the body, measured through lung function decline.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
"We believe Ofev may help address an unmet medical need by providing a therapy for patients across a spectrum of ILDs with a progressive phenotype," said Thomas Seck, M.D., senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We are encouraged by this Breakthrough Therapy Designation and look forward to working closely with the agency to offer this therapy to patients for which there are no FDA-approved treatment options."
The Breakthrough Therapy Designation process was established by the FDA to expedite the development and review of drugs for serious or life-threatening conditions where preliminary clinical evidence indicate that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. In July 2014, the FDA granted nintedanib Breakthrough Therapy Designation for the treatment of people with idiopathic pulmonary fibrosis (IPF) and approved the drug for that use in October 2014.
The efficacy and safety of nintedanib in the treatment of these ILDs has not been established. However, one of the expectations of investigational therapies that have Breakthrough Therapy Designation is that sponsors initiate a program to make the investigational therapy available to appropriate patients through a compassionate use program. BI has a compassionate use protocol that makes nintedanib available to appropriate patients who do not otherwise qualify or are unable to participate in clinical studies.