Boehringer Ingelheim Receives the CHMP Positive Opinion of Jascayd for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF)
Shots:
- The CHMP has recommended Jascayd (nerandomilast) for the treatment of adults with IPF and PPF
- Opinion was supported by the P-III (FIBRONEER-IPF and FIBRONEER-ILD) trials; both trials met their 1EPs, showing nerandomilast slowed lung function decline vs PBO through Wk-52. Nerandomilast also demonstrated a favorable safety/tolerability profile, with no liver monitoring requirement and PBO-like discontinuation rates as monotx.
- Jascayd (PO, BID) is a PDE4B inhibitor with antifibrotic and immunomodulatory effects, approved in the US, China, the UAE, and Japan for adults with IPF and PPF. Regulatory reviews are ongoing in the UK and other markets, with further approvals expected in 2026. Boehringer is also evaluating nerandomilast in SSc and IIM
Ref: Boehringer Ingelheim | Image: Boehringer Ingelheim |Press Release
Related News: Boehringer Ingelheim Receives the US FDA Approval of Jascayd (Nerandomilast) for Progressive Pulmonary Fibrosis
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