Ingelheim, Germany – May 22, 2026
Boehringer Ingelheim announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for JASCAYD® (nerandomilast) for adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in the European Union. The recommendation marks a major advancement for patients suffering from these progressive and life-threatening lung diseases and positions JASCAYD as the first new IPF treatment in Europe in more than a decade. The decision also strengthens Boehringer Ingelheim’s growing respiratory disease portfolio and highlights the increasing focus on innovative fibrosis therapies worldwide.
CHMP Positive Opinion Marks Major EU Milestone
The positive CHMP recommendation is based on findings from the company’s large-scale Phase III FIBRONEER™ clinical program, which evaluated the efficacy and safety of nerandomilast, a preferential PDE4B inhibitor with antifibrotic and immunomodulatory properties. According to Boehringer Ingelheim, both pivotal studies — FIBRONEER™-IPF and FIBRONEER™-ILD — successfully met their primary endpoint by demonstrating that JASCAYD significantly slowed the decline in lung function compared with placebo over 52 weeks.
The company stated that lung function decline was measured using forced vital capacity (FVC), one of the most important clinical indicators in pulmonary fibrosis management. While key secondary endpoints were not fully achieved, researchers observed a numerical reduction in mortality across both studies, with nominal significance reported in the FIBRONEER™-ILD trial. Importantly, JASCAYD demonstrated a favorable safety and tolerability profile, with no requirement for liver monitoring and discontinuation rates similar to placebo when used as monotherapy.
Boehringer executives emphasized that long-term treatment adherence remains critical for patients with pulmonary fibrosis, as many currently available therapies are associated with difficult side effects that often lead to treatment discontinuation. The company believes JASCAYD’s tolerability profile could improve sustained disease management for patients across Europe.
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New Hope for Patients With Progressive Lung Diseases
Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) are irreversible lung diseases characterized by continuous scarring of lung tissue, leading to worsening breathing difficulties and severe reductions in oxygen transfer. Together, the conditions affect more than 500,000 people across the European Union and millions globally. Approximately half of diagnosed patients die within five years, making pulmonary fibrosis deadlier than many common cancers.
Medical experts involved in the FIBRONEER™ program noted that patients urgently need therapies with new mechanisms of action that combine meaningful efficacy with improved tolerability. Current treatments are often associated with side effects including nausea, diarrhea, and photosensitivity, causing many patients to delay or discontinue therapy altogether. In IPF specifically, nearly half of treatment discontinuations occur within the first six months.
Patient advocacy groups also welcomed the positive CHMP opinion, highlighting the emotional and physical burden pulmonary fibrosis places on patients and families. Reduced lung function severely limits everyday activities such as walking, showering, and basic movement, creating significant declines in quality of life. A new treatment capable of slowing disease progression with fewer side effects could therefore provide substantial clinical and emotional benefits.
Boehringer Strengthens Global Fibrosis Leadership
JASCAYD has already received approvals in the United States, China, Japan, and the United Arab Emirates, making it the first and only oral preferential PDE4B inhibitor approved for IPF and PPF in multiple major global markets. Additional regulatory submissions remain under review in the United Kingdom and other countries, with further approvals anticipated during 2026.
Boehringer Ingelheim is also expanding the potential use of nerandomilast into other serious inflammatory and rheumatic conditions, including systemic sclerosis and idiopathic inflammatory myopathies. Analysts believe the company’s continued investment in fibrosis research could strengthen its long-term position in respiratory and immunology therapeutics while addressing major unmet medical needs worldwide.
The CHMP recommendation now moves JASCAYD one step closer to formal European Commission approval, which could provide thousands of patients across Europe access to a new generation of lung fibrosis therapy for the first time in years.
Source: Boehringer Ingelheim press release
