Boehringer Ingelheim Gains CHMP Backing for Nerandomilast in IPF and PPF Across EU

Boehringer Ingelheim's nerandomilast (Jascayd) has cleared the CHMP opinion stage, triggering a labeling and formulation review that manufacturers and QA leads supplying the EU market will need to track closely. The European Commission decision, which formally converts the CHMP recommendation into an EU-wide marketing authorisation, remains the next procedural gate before commercial supply can begin.

Nerandomilast is a PDE4B-preferential inhibitor indicated for adults with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). The recommended dose is 18 mg orally twice daily, with a permitted reduction to 9 mg twice daily for tolerability issues including diarrhoea or weight loss. A critical carve-out in the label: the dose reduction to 9 mg is contraindicated in patients co-administered pirfenidone, which reduces systemic nerandomilast exposure. That interaction creates a distinct labeling complexity for manufacturers producing combination therapy packs or unit-dose configurations for markets where pirfenidone use is prevalent.

The CHMP recommendation rests on two pivotal studies enrolling 2,355 patients. Effectiveness was measured by decline in forced vital capacity (FVC) over 52 weeks. In the IPF study, patients on 18 mg twice daily showed a mean FVC decline of approximately 115 ml versus 183 ml on placebo; the 9 mg arm recorded 139 ml. In the PPF study, FVC decline was approximately 99 ml (18 mg) and 85 ml (9 mg) against 166 ml for placebo. Both studies also indicated a mortality benefit, though the authorisation language does not quantify this as a primary endpoint. Roughly 78% of IPF patients and 44% of PPF patients in the trials were receiving background therapy concurrently, which contextualises the drug-drug interaction data for pirfenidone.

For QA directors and regulatory affairs leads, the pirfenidone interaction is the sharpest near-term compliance consideration. Labeling under 21 CFR Part 201 equivalents in the EU context will need to reflect the dose-modification restriction clearly, and any post-authorisation variation submissions touching dose strength or pack configuration will need to account for this interaction in the risk documentation. Process validation for the 9 mg and 18 mg tablet strengths will need to be treated as distinct commercial presentations with separate release specifications.

The dossier now moves to the European Commission; once the formal authorisation is issued, pricing and reimbursement negotiations proceed at the Member State level, meaning supply timelines will vary by market.

Plant heads planning capacity for Jascayd's EU launch should monitor the European Commission decision date as the trigger for commercial batch release obligations under GMP-compliant schedules.

Source: European Medicines Agency via ema.europa.eu, 22 May 2026.