FDA grants BI 1015550 Breakthrough status for IPF

The US Food and Drug Administration has granted Breakthrough Therapy designation to the novel investigational therapy, BI 1015550, for the treatment of idiopathic pulmonary fibrosis (IPF), which is under development by family-owned German drug major Boehringer Ingelheim.

BI 1015550 is an oral, phosphodiesterase 4B (PDE4B) inhibitor with the potential to address both pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function – and inflammation associated with progressive fibrosing interstitial lung diseases (ILDs).

“The accelerated development of BI 1015550 is part of Boehringer Ingelheim’s next wave of potential innovative treatments for interstitial lung diseases aimed at preserving lung function and improving the lives of patients,” said Dr Thomas Seck, senior vice president, medicine and regulatory affairs, at US subsidiary Boehringer Ingelheim Pharmaceuticals Inc.