Boehringer Ingelheim has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for Jascayd (nerandomilast) to treat adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
Jascayd is said to be the first phosphodiesterase 4B (PDE4B) inhibitor with antifibrotic and immunomodulatory effects to be approved for these uses. Japan is the fourth country to authorise nerandomilast.
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The approval is based on the Phase III FIBRONEER-IPF and FIBRONEER-ILD clinical trials conducted in parallel.
In FIBRONEER-IPF, the primary endpoint was achieved. Nerandomilast demonstrated a slower decline in lung function compared to placebo, as measured by absolute change in forced vital capacity (FVC) from baseline to week 52.
Similarly, FIBRONEER-ILD showed a statistically significant FVC benefit for nerandomilast at week 52, compared to placebo.
While both studies did not meet their key secondary endpoint, pooled analysis indicated a 59% reduction in the risk of death in the nerandomilast 18mg group without existing therapies.
This compared with placebo, showing a nominally significant difference.
Boehringer Ingelheim human pharma head and board of managing directors chairman Shashank Deshpande said: “Today’s approval of Jascayd in Japan marks a pivotal moment for people living with IPF and PPF and, in IPF, the first new treatment option in more than a decade.
“With Jascayd, physicians in Japan now have a new oral treatment option that combines clinically meaningful efficacy with a well-tolerated profile that can support sustained treatment, helping more patients stay on therapy and face the future with greater confidence.”
In both trials, nerandomilast showed statistically significant FVC improvements over placebo.
Last month, Boehringer and Zai Lab entered a clinical collaboration to investigate a dual delta-like ligand 3 (DLL3)-targeting approach for patients with extensive-stage small cell lung cancer (ES-SCLC) and other neuroendocrine carcinomas (NECs).
