CHMP issues positive opinion for JASCAYD® (nerandomilast), bringing a new IPF and PPF therapy closer to patients in the EU

Not intended for US and UK media

• Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) are life-threatening, progressive lung conditions that require early and sustained intervention1,2
• CHMP’s positive opinion is based on results from the Phase III FIBRONEER™️ program, assessing the efficacy and safety of nerandomilast in IPF and PPF3,4
• JASCAYD® (nerandomilast) is the first and only oral, preferential PDE4B inhibitor authorized for use in IPF and PPF in the US, China, the UAE, and Japan, and the first new IPF treatment in more than a decade

Ingelheim, Germany - 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.3,4 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.3,4 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.5 Nerandomilast demonstrated favorable safety and tolerability, with no requirement for liver monitoring. As monotherapy, it showed similar discontinuation rates to placebo.3,4 

“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.6 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 years7,8,9 – a prognosis worse than that of many cancers.8,10,11 Despite the high mortality rate, many people delay starting existing therapies due to side effects such as nausea, photosensitivity, and diarrhea.12,13 In IPF specifically, approximately half of those who stop do so within six months.14

“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.”

About IPF and PPF

Idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) are both conditions with irreversible build-up of scar tissue in the lungs, affecting the lungs’ ability to take in and transfer oxygen into the bloodstream.15,16,17 Once lung function is lost, it’s lost forever. Signs and symptoms of IPF and PPF include a persistent dry cough, shortness of breath, fatigue and finger/toe clubbing (widening and rounding of the tips of fingers/toes).2,17

In IPF, the root cause of pulmonary fibrosis is not known.14 The disease primarily affects people over the age of 50 and affects more men than women.18

In PPF, the scarring of the lungs may be linked to an existing condition (e.g. rheumatoid arthritis or systemic sclerosis), result from exposure to inhaled substances (e.g. asbestos or mold), or be due to an unknown cause (idiopathic) and worsens despite treatment of the condition.16 

Together, IPF and PPF may affect up to 9.2 million people worldwide.6,19 Approximately half of people with IPF or PPF die within 5 years of diagnosis7,8,9 – a higher mortality than many cancers.8,10,11

About nerandomilast

JASCAYD® (nerandomilast) is a twice daily oral, preferential PDE4B inhibitor with antifibrotic and immunomodulatory effects approved in the U.S., China, the United Arab Emirates, and Japan for the treatment of adults with IPF and for the treatment of adults with PPF.

Regulatory submissions for nerandomilast in IPF and PPF are also under review in the UK, and other countries with additional approvals anticipated in 2026. 

Boehringer Ingelheim is also exploring the potential of nerandomilast in two rheumatic diseases: systemic sclerosis (SSc) and myositis (IIM).

Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com. 

References

*FVC is a measure of lung function, measured in mL. 

**The key secondary endpoint was time to first acute IPF/ILD exacerbation, first hospitalization for respiratory cause, or death over the duration of trial 

1. Hoyer N, et al. Respir Res. 2019;20(1).
2. Grant-Orser A, et al. BMJ Open Respir Res. 2024;11:e002333.
3. Richeldi, et al. NEJM. 2025;392:2193-2202.
4. Maher T, et al. N Engl J Med. 2025;392(22):2203-2214.
5. Oldham JM, et al. ERS International Congress; 2025. Poster.
6. Cottin V, et al. Front Med (Lausanne). 2022;9:799912.
7. Zheng Q et al. ERJ Open Res. 2022;8(1):00591-2021.
8. Cen Z, et al. Ann Med. 2024;56(1):2406439.
9. Nasser M, et al. Respir Res 2021;22:162.
10. Siegel RL, et al. A Cancer Journal for Clinicians. 2024;74(1):12–49.
11. Vancheri C, et al. Eur Respir J. 2010;35(3):496–504.
12. Esbriet SmPC — Roche, 2014.
13. Ofev SmPC — Boehringer Ingelheim, 2025 (Last updated: Oct 2025).
14. Levra S et al. Biomedicines. 2022;10(12):3229.
15. Upagupta C, et al. Eur Respir Rev. 2018;27:180033.
16. Kondoh Y, Inoue Y. Adv Ther. 2025;42(7):2988–3001.
17. van Cleemput, J, et al. Adv Ther. 2019;36, 298–317.
18. Wang J, et al. MedComm (2020). 2024;5(10):e744.
19. Podolanczuk A, et al. Eur Respir J. 2023;614).