CHMP Backs Nerandomilast for IPF and PPF in EU

Nerandomilast (Jascayd; Boehringer Ingelheim) received a recommendation for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for treating adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).¹

This announcement marks a significant step toward access to this drug across the European Union (EU). Nerandomilast is already approved in the US, China, the United Arab Emirates, and Japan for treatment of adults with IPF and PPF. Although the CHMP has given a positive recommendation for the drug based on positive outcomes in clinical trials, an approval by the European Commission is not guaranteed, as the recommendation will be forwarded to the European Commission to make the final decision.² The CHMP recommendation was supported by evidence from the FIBRONEER-IPF (NCT05321069) and FIBRONEER-ILD (NCT05321082) clinical trials.

What a Positive CHMP Opinion Means for Nerandomilast in Europe

“The CHMP’s positive opinion for [nerandomilast] reflects the growing recognition that meaningful efficacy alongside a well‑tolerated profile is essential for enabling sustained treatment in IPF and PPF,” Shashank Deshpande, chairman of the board of managing directors and head of human pharma at Boehringer Ingelheim, said in a press release. “[And] addresses the high unmet need for patients whose prognosis is worse than that of many common cancers.”

The phase 3, double-blind trial randomly assigned patients with IPF 1:1:1 to receive an 18 mg or 9 mg dose of nerandolimast or a placebo twice daily. The study met its primary end point in absolute change from baseline forced vital capacity (FVC) at 52 weeks.³ Over the 52-week period, nerandomilast significantly slowed the decline in FVC when compared with the placebo.

Overall, patients who received 18 mg of nerandomilast twice daily had a significantly smaller change in FVC from baseline (–114.7 ml [95% confidence interval (CI), –141.8 to –87.5]) when compared with the 9 mg group (–138.6 ml [95% CI, –165.6 to –111.6]) and the placebo group (–183.5 ml [95% CI, –210.9 to –156.1]).³ The key secondary end point was not met.¹

“This is imperative in conditions like IPF and PPF, including patients with an associated autoimmune rheumatic disease, which can worsen suddenly and unpredictably,” Anna‑Maria Hoffmann‑Vold, MD, PhD, professor of rheumatology at the University of Zurich and Oslo University Hospital and investigator in the FIBRONEER program, said in a press release. “Maintaining lung function for longer can therefore make a meaningful difference in clinical practice.”

Nerandomilast Could Expand Treatment Options for IPF and PPF

Nerandomilast is the first oral antifibrotic agent in years to demonstrate meaningful effects on lung function.⁴ This drug has the potential to impact the lives of the nearly 500,000 people living in the EU with IPF or PPF—half of whom succumb to the disease within 5 years after diagnosis. Despite the current therapies approved in the EU to treat adults with IPF and PPF, nintedanib (Ofev; Boehringer Ingelheim) and pirfenidone (Esbriet; Roche in the EU), many patients delay treatment due to adverse effects (AEs). ¹

AEs associated with nintedanib and pirfenidone include nausea, photosensitivity, and diarrhea.¹ The most frequently reported AE in the FIBRONEER-IPF trial was diarrhea, which was reported in 41.3% of the 18 mg group, 31.1% of the 9 mg group, and 16.0% in the placebo group.³ However, a new systematic review and meta-analysis of the FIBRONEER-IPF clinical trial data showed no significant difference in the overall risk of side effects between nerandomilast and the placebo.⁴

“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,” John K. Solheim, president of the European Pulmonary Fibrosis Federation, said in a press release. “A treatment option for IPF and PPF that works and has fewer side effects offers real hope to families across Europe.”¹

References

1. Limited BI. CHMP issues positive opinion for Jascayd (nerandomilast), bringing a new IPF and PPF therapy closer to patients in the EU. News release. Boehringer Ingelheim. May 22, 2026. Accessed June 10, 2026. https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/chmp-issues-positive-opinion-jascayd-ipf-and-ppf-eu

2. Obtaining an EU marketing authorisation, step-by-step. European Medicines Agency (EMA). July 31, 2023. Accessed June 10, 2026. https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step

3. Richeldi L, Cottin V, Kreuter M, et al. Nerandomilast in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2025;392:2193-2202. doi:10.1056/NEJMoa2414108

4. AJMC contributor. Nerandomlaist shows promise in slowing lung function decline in pulmonary fibrosis. AJMC^®. March 27, 2026. Accessed June 10, 2026. https://www.ajmc.com/view/nerandomilast-shows-promise-in-slowing-lung-function-decline-in-pulmonary-fibrosis