Boehringer Ingelheim announced that FDA has granted Orphan Drug Designation to BI 1819479 for the potential treatment of idiopathic pulmonary fibrosis (IPF).
BI 1819479 is an investigational compound that may address pulmonary fibrosis—a scarring of the lung tissue that negatively impacts lung function—associated with IPF, a type of interstitial lung disease.
This compound is an investigational agent and has not been approved by any regulatory authority, including the FDA. The safety and efficacy of this investigational compound has not been established.
The FDA grants Orphan Drug Designation to investigational compounds intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.
“Idiopathic pulmonary fibrosis is a serious disease that can cause irreversible scarring of the lungs and worsen over time, to a point where individuals living with the disease may experience symptoms that can make it difficult to complete daily activities,” said Leticia Orsatti, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim. “This designation signals an important milestone in Boehringer Ingelheim’s mission to pioneer potential new treatment options that ultimately help support those affected by pulmonary fibrosis.”
The FDA granted Orphan Drug Designation to BI 1819479 based on the availability of preclinical data. A phase II clinical trial is scheduled to begin in 2024.
