German pharmaceutical giant Boehringer Ingelheim has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review status to its investigational drug nerandomilast. The drug is being developed for the treatment of idiopathic pulmonary fibrosis (IPF), a rare and debilitating lung disease that was included in China’s second batch list of rare diseases in 2018.
Positive Phase III Results
Nerandomilast, an oral phosphodiesterase 4B (PDE4B) inhibitor, demonstrated significant efficacy in the pivotal Phase III FIBRONEER-IPF study. The drug achieved the primary endpoint by significantly improving the forced vital capacity (FVC) of patients at week 52. This milestone underscores the potential of nerandomilast to address the unmet medical needs of patients with IPF, a condition characterized by progressive scarring of the lungs and severe respiratory impairment.
Priority Review and Future Implications
The priority review status granted by the CDE highlights the urgent need for effective treatments for IPF and the potential of nerandomilast to make a meaningful difference. This designation is expected to accelerate the regulatory review process, bringing the drug closer to potential approval and commercialization in China. Boehringer Ingelheim’s commitment to advancing treatments for rare diseases is evident through its robust clinical development program and the promising results of the FIBRONEER-IPF study.-Fineline Info & Tech
Leave a Reply