Boehringer Ingelheim Bolsters Pulmonary Fibrosis Portfolio with Jascayd Approval for Progressive Cases

Boehringer Ingelheim announced US Food and Drug Administration clearance for Jascayd (nerandomilast) tablets to treat progressive pulmonary fibrosis in adults. This marks the second indication for the therapy, following its recent approval for idiopathic pulmonary fibrosis.

Jascayd introduces the first selective phosphodiesterase 4B inhibitor with both immune-modulating and anti-scarring properties approved for this serious lung disorder.

FIBRONEER-ILD Trial Supports Approval

The approval stems from the phase III FIBRONEER-ILD study, the most extensive trial conducted in progressive pulmonary fibrosis patients to date. Nerandomilast significantly slowed the typical drop in lung capacity compared to placebo, with dropout rates matching those in the control group.

The main goal measured change in forced vital capacity from the start of treatment through week 52. Patients on nerandomilast 18 mg twice daily saw an average decline of 86 mL, while the 9 mg dose group experienced 69 mL decline, versus 152 mL in placebo recipients. This translated to treatment benefits of 65 mL and 83 mL over placebo, respectively.

Side effects in progressive pulmonary fibrosis patients mirrored those seen in idiopathic pulmonary fibrosis trials.

Key Secondary and Exploratory Findings

A major secondary measure tracked time to first serious event, including sudden lung worsening, respiratory-related hospital stays, or death, over up to 109 weeks. While overall differences did not reach statistical significance, exploratory reviews of the 18 mg dose showed reduced risk for acute lung flares and hospital admissions.

Survival analysis through 114 weeks favored nerandomilast, though these were not part of the planned statistical testing.

Safety and Tolerability Profile

Nerandomilast proved generally well-tolerated across the study population. Diarrhea emerged as the leading side effect, appearing more often when combined with nintedanib, 49% and 50% in 18 mg and 9 mg groups versus 37% on placebo plus nintedanib.

About Jascayd (nerandomilast) - Mechanism of action

Jascayd offers oral therapy as a targeted PDE4B blocker for adult idiopathic pulmonary fibrosis and progressive pulmonary fibrosis patients in the US and China. Applications for both uses remain under review in Europe, the UK, Japan, and beyond, with additional nods expected next year.