The European Commission has approved JASCAYD (nerandomilast), a first-in-class oral therapy for adults living with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
Thus, marking the first new treatment approval for IPF in the European Union in more than a decade and the first for PPF in more than five years.
Developed by Boehringer Ingelheim, JASCAYD is the first preferential phosphodiesterase 4B (PDE4B) inhibitor approved in the EU, offering a new approach with antifibrotic and immunomodulatory effects for two progressive and life-threatening lung conditions.
The approval is based on results from the Phase III FIBRONEER clinical program, the largest trial program conducted to date in IPF and PPF. The studies showed that nerandomilast significantly slowed lung function decline, measured by changes in forced vital capacity (FVC), compared with placebo.
The therapy also demonstrated a favorable safety and tolerability profile, with monotherapy discontinuation rates similar to placebo and no requirement for liver monitoring.
“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.”
IPF and PPF affect more than 500,000 people across Europe, causing permanent scarring of the lungs that progressively limits breathing. Around half of people diagnosed with these conditions die within five years — a prognosis worse than many cancers.
For many patients, existing treatments can be difficult to tolerate, with side effects including nausea, photosensitivity and diarrhea leading some to discontinue therapy.
“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.”
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