Overview
- The CHMP issued a positive opinion recommending EMA grant marketing authorisation for Jascayd (nerandomilast) for adults with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis, a decision published on May 22, 2026.
- The recommendation rests on two randomized trials of 2,355 patients in which Jascayd slowed decline in forced vital capacity over one year compared with placebo, and the study results suggested a reduction in mortality.
- Trial results showed average 1‑year FVC declines of about 115 ml (18 mg twice daily) and 139 ml (9 mg twice daily) for IPF patients versus 183 ml with placebo, and roughly 99 ml and 85 ml respectively for PPF patients versus 166 ml with placebo.
- Nerandomilast targets lung-expressed enzyme PDE4B to reduce fibrosis and inflammation; the recommended dose is 18 mg twice daily with an option to reduce to 9 mg twice daily for intolerance, and the most common side effects were diarrhoea and weight loss.
- The CHMP opinion will be sent to the European Commission for a final EU decision and, if authorised, each EU member state will negotiate price and reimbursement which will shape when and how patients can access the medicine.