European Commission approves Jascayd (nerandomilast) bringing well-tolerated, novel oral treatment for IPF and PPF to the EU – Boehringer
Boehringer Ingelheim 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. 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. 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. Nerandomilast demonstrated a favorable safety and tolerability profile with no requirement for liver monitoring. As monotherapy, it showed similar discontinuation rates to placebo.
“One of the challenges of managing IPF and PPF is seeing patients needing to stop treatment early because the side effects are too much to tolerate,” said Prof Marlies Wijsenbeek, Pulmonary Physician at the Erasmus MC University Medical Centre. “The FIBRONEER trials showed us that nerandomilast preserves lung function with a tolerability profile that allows patients to stay on their medication, which is a major clinical advancement that patients across the EU have been waiting for. Also, removing the burden of ongoing liver monitoring is an additional improvement for patients.”
IPF and PPF affect more than 500,000 people across Europe, causing irreversible lung scarring that severely restricts breathing. Despite the life-threatening nature of these conditions, where approximately half of those diagnosed lose their lives within five years – a prognosis worse than many cancers – many people delay or stop existing therapies due to side effects such as nausea, photosensitivity, and diarrhea. In IPF specifically, approximately half of those who stop therapy do so within six months.
“When diagnosed with a progressive and irreversible lung condition like IPF or PPF, your greatest fear is running out of treatment options,” said Sue Farrington, President of the Federation of European Scleroderma Associations (FESCA). “Today’s authorization is a long-awaited breakthrough for the IPF and PPF community in the EU and offers renewed hope for people living with systemic sclerosis and other diseases that can lead to progressive lung fibrosis. Having a therapy that patients can reliably stay on to preserve their lung health brings real stability and hope to families.”
