Boehringer Ingelheim’s Nerandomilast Filing Accepted for Review in Progressive Pulmonary Fibrosis

Boehringer Ingelheim's Nerandomilast Filing Accepted for Review in Progressive Pulmonary Fibrosis

Boehringer Ingelheim announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the filing for another indication approval of its investigational drug nerandomilast for the treatment of progressive pulmonary fibrosis (PPF). The preferential inhibitor of phosphodiesterase 4B (PDE4B) is also awaiting regulatory decisions from the NMPA for the treatment of idiopathic pulmonary fibrosis (IPF).

Phase III Study Results
The summary results of the pivotal Phase III FIBRONEER-ILD study demonstrated promising outcomes. At week 52 of treatment with nerandomilast, the absolute change in forced vital capacity (FVC, mL) from baseline reached the primary endpoint compared to placebo. This indicates the potential of nerandomilast to address the unmet medical needs in patients with progressive pulmonary fibrosis.-Fineline Info & Tech