Boehringer Ingelheim's nerandomilast wins NMPA approval in China for progressive pulmonary fibrosis

On December 10, Boehringer Ingelheim announced that the National Medical Products Administration (NMPA) of China has approved nerandomilast for the treatment of adult patients with progressive pulmonary fibrosis (PPF). Nerandomilast is a selective phosphodiesterase 4B (PDE4B) inhibitor that simultaneously exhibits immunomodulatory, vascular protective, and anti-fibrotic effects. Following its recent approvals in the United States and China for the treatment of idiopathic pulmonary fibrosis (IPF), PPF represents the second approved indication for nerandomilast.

Progressive pulmonary fibrosis (PPF) is a progressive and ultimately fatal disease characterized by irreversible lung scarring that worsens over time. As the condition advances, patients experience increasing difficulty with daily activities and face a rising risk of death. Unfortunately, PPF patients often experience delays in diagnosis or interruptions in treatment, leading to continued disease progression, worsening symptoms, and a decline in quality of life.

Nerandomilast is an oral, selective phosphodiesterase 4B (PDE4B) inhibitor, now approved in China for the treatment of both idiopathic pulmonary fibrosis (IPF) and PPF in adults. In the United States, the drug has been granted Priority Review and Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) and is already approved for the treatment of IPF. Currently, the FDA is conducting a Priority Review of nerandomilast for the treatment of adult PPF.

This approval is based on the results of the pivotal Phase 3 clinical trial, FIBRONEER™-ILD. The data showed that nerandomilast met its primary endpoint: the absolute change from baseline in forced vital capacity (FVC) [mL] at week 52 compared to the placebo group. FVC is a key indicator for measuring lung function, and the findings demonstrate that the drug can effectively slow the decline in lung function in patients with PPF. Furthermore, nerandomilast exhibited a favorable safety and tolerability profile, with a low discontinuation rate and no requirement for liver function monitoring. The FIBRONEER™-ILD study also indicated that nerandomilast improved patient survival, showing a nominally significant reduction in the risk of death.