Healthcare
European Commission approves JASCAYD®, bringing well-tolerated, novel oral treatment for IPF and PPF to the EU
Boehringer headquarters Boehringer headquarters, Ingelheim, Germany Not intended for UK and US audiences JASCAYD® (nerandomilast) is the first oral, preferential PDE4B inhibitor approved in the European Union, delivering a novel mechanism of action with antifibrotic and immunomodulatory effectsPhase III FIBRONEER™️trials demonstrated that nerandomilast effectively slows lung function decline in adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF),
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Boehringer headquarters Not intended for UK and US audiences Ingelheim, Germany - Boehringer Ingelheim today announced that the European Commission (EC) has granted marketing authorization for JASCAYD® (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF). This marks the first new treatment approved in IPF in the EU in over a decade and for PPF in more than five years. As a first-in-class oral preferential phosphodiesterase 4B (PDE4B) inhibitor, nerandomilast addresses a critical unmet need by successfully slowing disease progression while remaining tolerable. "With JASCAYD®, physicians across the EU gain a long-awaited, new treatment option for people living with IPF and PPF that is effective, has a well-characterized safety profile and may support long-term adherence," said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. "This milestone is a major advancement, but it must also be a catalyst for broader recognition that lungs can't wait. Earlier recognition and diagnosis of pulmonary fibrosis are crucial because for people living with a progressive disease, every moment matters." The EC approval follows the positive CHMP opinion received in May and is based on results from the FIBRONEER™ Phase III program, the largest clinical trial program conducted in IPF and PPF to date.1,2 In both the FIBRONEER™-IPF and FIBRONEER™-ILD trials, the primary endpoint was met: nerandomilast successfully slowed lung function decline, measured by absolute change in forced vital capacity (FVC)* from baseline to week 52 compared to placebo.1,2 While the key secondary endpoint was not met in either trial,** a numerical reduction in mortality was observed across both trials, reaching nominal significance in FIBRONEER™-ILD.1,2 Nerandomilast demonstrated a favorable safety and tolerability profile with no requirement for liver monitoring. As monotherapy, it showed similar discontinuation rates to placebo.1,2