CHMP issues positive opinion for Jascayd (nerandomilast) bringing a new IPF and PPF therapy closer to patients in the EU – Boehringer Ingelheim
Boehringer Ingelheim’s Jascayd (nerandomilast) has been recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF). This marks an important step toward making the first preferential PDE4B inhibitor available to patients living with these progressive and life-threatening lung conditions across the European Union.
“The CHMP’s positive opinion for Jascayd reflects the growing recognition that meaningful efficacy alongside a well‑tolerated profile is essential for enabling sustained treatment in IPF and PPF. This is vital to slow down the irreversible and life-threatening damage to the lungs and to address the high unmet need for patients whose prognosis is worse than that of many common cancers,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “If approved in the EU, Jascayd would mark the first new treatment option for IPF in Europe in more than a decade.”
The positive CHMP opinion is supported by results from FIBRONEER, the largest clinical trial program in IPF and PPF to date. Both Phase III trials, FIBRONEER-IPF and FIBRONEER-ILD, met their primary endpoint, demonstrating that nerandomilast 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, there was a numerical reduction in mortality across both, reaching nominal significance in FIBRONEER-ILD. Nerandomilast demonstrated favorable safety and tolerability, with no requirement for liver monitoring. As monotherapy, it showed similar discontinuation rates to placebo.
“Current treatments for IPF and PPF, including in patients whose PPF is associated with underlying autoimmune rheumatic diseases, have well‑known limitations. This is why advancing therapies with new mechanisms of action and better tolerability profiles is essential to improving how we manage these complex diseases,” said Professor Anna‑Maria Hoffmann‑Vold, Professor of Rheumatology at the University of Zurich and Oslo University Hospital and investigator in the FIBRONEER program. “In the FIBRONEER trials, nerandomilast was well‑tolerated and slowed lung function decline, supporting its potential for long‑term use. This is imperative in conditions like IPF and PPF, including patients with an associated autoimmune rheumatic disease, which can worsen suddenly and unpredictably. Maintaining lung function for longer can therefore make a meaningful difference in clinical practice.”
Together, IPF and PPF affect more than 500,000 people across the EU. Both conditions are characterized by irreversible scarring of lung tissue that worsens over time, limiting people’s ability to breathe. Approximately half of those diagnosed with IPF or PPF lose their lives within five years – a prognosis worse than that of many cancers. Despite the high mortality rate, many people delay starting existing therapies due to side effects such as nausea, photosensitivity, and diarrhea. In IPF specifically, approximately half of those who stop do so within six months.
“The emotional toll of living with pulmonary fibrosis is overwhelming. This disease takes away independence, and the impact of losing the ability to do simple everyday tasks, such as showering, walking to the car, or catching your breath, is profound,” said John K. Solheim, President of the European Pulmonary Fibrosis Federation (EU‑PFF). “When patients are faced with treatment options that add unbearable side effects to the already burdensome symptoms, many choose to delay or stop taking them. A treatment option for IPF and PPF that works and has fewer side‑effects offers real hope to families across Europe.”
