Boehringer Ingelheim announced that its investigational drug nerandomilast has been accepted for review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The German pharma giant seeks approval for the oral phosphodiesterase 4B (PDE4B) inhibitor to treat idiopathic pulmonary fibrosis (IPF) in adults.
Clinical Trial Results
The filing was supported by data from the Phase III FIBRONEER-IPF study, which showed nerandomilast significantly improved forced vital capacity (FVC) compared to placebo. At 52 weeks, patients treated with nerandomilast demonstrated a notable increase in absolute FVC changes from baseline.
Drug Mechanism
Nerandomilast acts as a preferential PDE4B inhibitor, targeting the enzyme to delay fibrosis and inflammation. The NMPA previously granted the drug priority review status, accelerating its regulatory pathway.-Fineline Info & Tech
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