Boehringer Ingelheim announced that it has launched an open-label, multicenter expanded access program (EAP) in the U.S. for its investigational compound nintedanib. The drug will be available patients diagnosed with idiopathic pulmonary fibrosis (IPF).
Nintedanib is an investigational small molecule tyrosine kinase inhibitor (TKI) under investigation for the treatment of idiopathic pulmonary fibrosis (IPF). The drug targets growth factors implicated in pulmonary fibrosis. These factors include vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR). The drug has not yet been approved by the FDA.
The nintedanib EAP is a single arm, open label, multicenter trial for patients with idiopathic pulmonary fibrosis who have been diagnosed with the disease within the last five years, in accordance with the most recent guidelines according to the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS) and Latin American Thoracic Association (ALAT). The trial will not compare nintedanib as treatment with any other IPF therapy.
Tunde Otulana, SVP of Clinical Development and Medical Affairs at Boehringer Ingelheim, said, “IPF is a rare and devastating disease with a very high mortality rate. There are currently no FDA-approved treatments and most patients die from their disease within three to five years of diagnosis. Boehringer Ingelheim wants to make nintedanib, an investigational drug currently in development for the treatment of IPF, available to patients who are ineligible or unable to take part in our ongoing clinical trial program.”
Idiopathic pulmonary fibrosis is a chronic, severely debilitating, progressive, and ultimately deadly lung disease for which there are no FDA-approved treatments. The disease is characterized by progressive scarring of lung tissue and a decrease of lung function over time. Research indicates that the incidence of IPF in the population might be increasing. The FDA allows drug makers with candidates in the late stages of development to offer patients access to investigational drugs. Such EAP are provided for patients who may not meet the qualifications to join a clinical trial but who have serious or immediately life-threatening illnesses with no alternative or effective treatment options.