Boehringer’s nerandomilast Phase III win sets stage for FDA filing

Boehringer Ingelheim today announced that the FIBRONEER-IPF trial met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity [mL] (FVC) at week 52 versus placebo. FVC is a measure of lung function.

The German family-owned pharma major noted that the key secondary endpoint of the trial was time to the first occurrence of any of the components of the composite endpoint: time to first acute idiopathic pulmonary fibrosis(IPF) exacerbation; first hospitalization for respiratory cause; or death (whichever occurs first) over the duration of the trial.

Based on these results, Boehringer said it will submit the new drug application (NDA) for nerandomilast for the treatment of IPF to the US Food and Drug Administration (FDA) and other health authorities worldwide. The FDA granted Breakthrough Therapy designation for the drug in IPF in 2022.