Boehringer Ingelheim: CHMP backs JASCAYD (nerandomilast) for IPF and PPF
- CHMP issued a positive opinion recommending EU marketing authorisation for JASCAYD (nerandomilast) for adults with IPF and PPF.
- Phase III FIBRONEER‑IPF and FIBRONEER‑ILD met the primary endpoint: nerandomilast slowed absolute FVC decline from baseline to week 52 versus placebo.
- The key secondary composite endpoint was not met, but mortality showed a numerical reduction across trials and reached nominal significance in FIBRONEER‑ILD.
- Nerandomilast is a twice‑daily oral preferential PDE4B inhibitor authorised in the US, China, the UAE and Japan; UK review and further approvals are anticipated in 2026.
CHMP recommendation
The Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending marketing authorisation in the EU for JASCAYD (nerandomilast) for adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
Clinical evidence
The opinion is based on the Phase III FIBRONEER programme—the largest clinical trial programme in IPF and PPF to date. Both FIBRONEER‑IPF and FIBRONEER‑ILD met their primary endpoint: nerandomilast slowed lung function decline measured as absolute change in forced vital capacity (FVC) from baseline to week 52 versus placebo. The trials did not meet the predefined key secondary endpoint (time to first acute IPF/ILD exacerbation, first respiratory hospitalization, or death), although there was a numerical reduction in mortality across both studies and nominal significance in FIBRONEER‑ILD.
Safety and tolerability
Nerandomilast demonstrated a favorable safety and tolerability profile in the trials, with no requirement for liver monitoring and similar discontinuation rates to placebo when used as monotherapy.
Unmet need and burden
IPF and PPF cause irreversible lung scarring and together affect more than 500,000 people in the EU and up to 9.2 million worldwide. Approximately half of those diagnosed die within five years. Existing therapies have known side effects (nausea, photosensitivity, diarrhea) that lead many patients to delay or stop treatment; about half of IPF patients who discontinue do so within six months.
Regulatory outlook and development plans
Nerandomilast is already authorised for IPF and PPF in the US, China, the UAE and Japan. Regulatory submissions are under review in the UK, and additional approvals are anticipated in 2026. The compound is also being explored in systemic sclerosis and idiopathic inflammatory myopathies (myositis).
Source: Boehringer Ingelheim
