- Nerandomilast approved in China for IPF based on Phase III FIBRONEER-IPF trial results.
- The trial showed significant improvements in Forced Vital Capacity at 52 weeks.
- Nerandomilast was included in the priority review by China's CDE and recently FDA-approved.
- A submission for progressive pulmonary fibrosis is under review with China's NMPA.
Approval and Trial Results
Nerandomilast, marketed as JASCAYD®, has been approved by China's National Medical Products Administration (NMPA) for treating idiopathic pulmonary fibrosis (IPF) in adults. This approval is based on the Phase III FIBRONEER-IPF trial, which demonstrated statistically significant improvements in Forced Vital Capacity (FVC) at 52 weeks compared to placebo.
Regulatory Review and Approvals
Nerandomilast was prioritized for review by the Centre for Drug Evaluation (CDE) of the NMPA earlier this year and recently received FDA approval in the United States. This marks the first IPF treatment approval in over a decade.
Clinical Significance
The FIBRONEER-IPF trial, the largest Phase III study in IPF treatment to date, confirmed that nerandomilast effectively slows lung function decline. The drug also showed favorable tolerability and safety, with discontinuation rates similar to placebo.
Future Prospects
A regulatory submission for nerandomilast in progressive pulmonary fibrosis (PPF) is currently under review with the NMPA in China, indicating potential future applications for the drug.
