Shots:The EC has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) & adults with progressive pulmonary fibrosis (PPF)Approval was based on the P-III (FIBRONEER) program, comprising the FIBRONEER-IPF & FIBRONEER-ILD trials. Both met their 1EP, demonstrating that Jascayd slowed lung function decline, measured by the change in FVC…
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…
Shots:The US FDA has approved Jascayd for the treatment of adults with progressive pulmonary fibrosis (PPF)Approval was based on the P-III (FIBRONEER-ILD) trial of Jascayd vs PBO, where Jascayd significantly reduced lung function decline at Wk. 52, with FVC decreases of 86mL (18mg) & 69mL (9mg) vs 152mL with PBO, showing clinically meaningful…
Shots:The Chinese NMPA has approved Boehringer Ingelheim's Jascayd for the treatment of adults with progressive pulmonary fibrosis (PPF)Approval was based on the P-III (FIBRONEER-ILD) trial of Jascayd vs PBO, which met its 1EP of reduced FVC at Wk. 52 & showed a significant reduction in death risk Additionally, Jascayd'ssNDA for PPF is under…

