Japan’s MHLW has approved Boehringer Ingelheim’s JASCAYD® (nerandomilast) for adults with IPF and PPF, marking the first approval of an oral PDE4B inhibitor and the first new IPF treatment option in more than a decade.
Written By: Farha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
Boehringer Ingelheim announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved JASCAYD® (nerandomilast) for adults with Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF). Japan becomes the fourth country after the United States, China, and the United Arab Emirates to approve nerandomilast. JASCAYD® is the first oral phosphodiesterase 4B (PDE4B) inhibitor approved for IPF and PPF and the first new IPF treatment option introduced in more than a decade.
Phase III FIBRONEER™ Trial Results
The approval was supported by the Phase III FIBRONEER™-IPF (NCT05321069) and FIBRONEER™-ILD (NCT05321082) trials, which enrolled more than 1,100 patients globally, making it the largest late-stage clinical program conducted in IPF and PPF. Both studies included patients receiving background antifibrotic therapy, including pirfenidone or nintedanib. Nerandomilast significantly slowed lung function decline versus placebo over 52 weeks in both trials.
In FIBRONEER™-IPF, nerandomilast reduced the annual rate of forced vital capacity (FVC) decline versus placebo by 44.9 mL in the 9 mg group and 68.8 mL in the 18 mg group. In FIBRONEER™-ILD, the reduction versus placebo was 81.1 mL and 67.2 mL in the respective dose groups.
Although the predefined key secondary endpoint was not met, an exploratory pooled analysis showed a 59% reduction in mortality risk among patients receiving the 18 mg dose without background antifibrotic therapy compared with placebo.
Arata Azuma, MD, PhD, Head of the Department of Respiratory Medicine, Tokorozawa Mihara General Hospital/Emeritus Professor, Nippon Medical School stated that IPF and PPF remain difficult-to-treat diseases with limited therapeutic progress over the past decade. He highlighted nerandomilast’s antifibrotic and anti-inflammatory effects alongside reduced lung function decline in the FIBRONEER™ trials.
Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim stated that the approval marks a pivotal moment for patients with IPF and PPF and introduces the first new IPF treatment option in over a decade. He added that the therapy combines meaningful efficacy with a well-tolerated safety profile.
Safety and Tolerability
The therapy demonstrated a generally consistent safety profile across both trials. Diarrhea was the most frequent adverse event, generally mild to moderate in severity and manageable with supportive care. In FIBRONEER™-IPF, diarrhea occurred in 16.0% of placebo patients versus 31.1% and 41.3% in the 9 mg and 18 mg groups, respectively. In FIBRONEER™-ILD, rates were 24.7%, 29.5%, and 36.6%, respectively. Treatment discontinuation rates due to adverse events were generally comparable across groups.
About JASCAYD® (Nerandomilast)
JASCAYD® is an oral PDE4B inhibitor with antifibrotic and immunomodulatory properties approved in the United States, China, the United Arab Emirates, and Japan for adults with IPF and PPF. Regulatory submissions remain under review in the European Union, the United Kingdom, and additional countries.
Boehringer Ingelheim is also evaluating nerandomilast in rheumatic diseases including systemic sclerosis and idiopathic inflammatory myopathies. With ongoing regulatory reviews in Europe and other regions, the company aims to expand global access to JASCAYD®.
Reference
JASCAYD approved in Japan new IPF and PPF treatment | Boehringer Ingelheim
About the Writer
Farha Farheen, PharmD (LinkedIn) is a pharmacy professional with a strong interest in pharmacovigilance and clinical research. She has completed her Doctor of Pharmacy (Pharm.D) along with her internship as a Clinical Pharmacist. She has hands-on experience in adverse drug reaction (ADR) reporting, safety data documentation, and pharmacovigilance workflows, and is proficient in using VigiFlow. She is also a patent holder for an antibacterial formulation enriched with bioactive substances, granted by the German Patent and Trademark Office.