U.S. FDA Grants BI 1819479 Orphan Drug Designation for Idiopathic Pulmonary Fibrosis

Ridgefield, Conn., November 10, 2023 | Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (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.

About IPF
Idiopathic pulmonary fibrosis (IPF) is one of the more common progressive fibrosing interstitial lung diseases. Symptoms of IPF include breathlessness during activity, a dry and persistent cough, chest discomfort, fatigue and weakness. Although considered “rare,” IPF affects approximately 3 million people worldwide. The disease primarily affects patients over the age of 50 and affects more men than women.

About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at boehringer-ingelheim.com/us/.

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