- JASCAYD® (nerandomilast) is approved in China for progressive pulmonary fibrosis (PPF).
- PPF affects up to 5.6 million people worldwide, with high mortality rates.
- Nerandomilast is a PDE4B inhibitor with immunomodulatory, vascular, and antifibrotic effects.
- Regulatory submissions for nerandomilast are under review in the EU, UK, Japan, and other countries.
Approval and Significance
JASCAYD® (nerandomilast) has received approval in China for treating progressive pulmonary fibrosis (PPF), marking the first new treatment option in over five years. This approval is based on the largest clinical trial program for PPF to date, offering a new option for patients with limited treatment choices.
Clinical Trial Results
The approval is supported by the Phase III FIBRONEER™-ILD trial, where nerandomilast met its primary endpoint, showing a significant reduction in the decline of lung function as measured by Forced Vital Capacity (FVC). The drug demonstrated favorable safety and tolerability, with low discontinuation rates and no need for liver monitoring.
Impact of PPF
PPF is a rare, life-threatening lung condition affecting up to 5.6 million people globally. It leads to irreversible lung scarring and is associated with high mortality rates, often linked to underlying diseases like rheumatoid arthritis or exposure to harmful substances. Diagnosis is often delayed, and many patients remain untreated.
Future Prospects
Nerandomilast is also approved in the U.S. for idiopathic pulmonary fibrosis (IPF) and is under priority review by the FDA for PPF. Regulatory submissions are ongoing in the European Union, UK, Japan, and other countries, with additional approvals expected by 2026.
