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The European Medicines Agency (EMA) has recommended granting marketing authorization for Jascayd (nerandomilast, Boehringer Ingelheim International GmbH) to treat adults with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).

The opinion will now be sent to the European Commission for a decision on an EU-wide marketing authorization. 

IPF is a chronic, progressive, fibrosing, interstitial pneumonia and the most common type of pulmonary fibrosis. PPF is a distinct form of progressive and fibrotic disease that occurs in cases of interstitial lung disease other than IPF. 

Both conditions typically occur in older adults. Symptoms can include difficulty in breathing that leads to hospitalization and mortality within a few years of diagnosis, due to progressive decline in lung function. Around 200,000 people live with IPF in Europe, while an estimated 2-20 people per 100,000 have PPF.

The active substance in Jascayd, nerandomilast, is an immunosuppressant that is a selective inhibitor of phosphodiesterase 4 (PDE4) with antifibrotic and immunomodulatory effects. It works by reducing the expression of profibrotic growth factors and inflammatory cytokines that are overexpressed in fibrotic lung disease. 

The EMA’s decision follows results from two phase 3, placebo-controlled, double-blind trials, one investigating nerandomilast for IPF and the other for PPF. The studies involved 1177 and 1176 patients, respectively. Among the patients who received nerandomilast, some received it alone and others took it alongside existing background treatments. 

Patients in both studies received either 9 or 18 mg of nerandomilast twice per day. The primary endpoint in both studies was the absolute change from the beginning of the study in forced vital capacity (FVC) at week 52. 

Across both trials, declines in FVC were significantly less in patients taking nerandomilast than in those taking placebo. In the IPF group, average FVC reductions were 115 mL for those taking the 18-mg dose, 139 mL for those on the 9-mg dose, and 183 mL for those on placebo. In the PPF group, average FVC reductions were limited to 99 mL for the 18-mg dose and 85 mL for the 9-mg dose, compared with a 166-mL reduction in lung capacity for those on the placebo.

The most common adverse event among those taking nerandomilast in both groups was diarrhea, reported most often in those taking 18 mg, followed by the 9-mg group. In both groups, the incidence of diarrhea was higher among patients taking background nintedanib therapy. Serious adverse events occurred at a similar rate across all patients in both studies. 

Jascayd will be available as 9-mg and 18-mg film-coated tablets. The recommended dose is 18 mg twice daily, but this may be reduced to 9 mg twice daily if the patient experiences diarrhea or weight loss. The 18-mg dose should not be reduced in patients also taking pirfenidone, as this medicine reduces levels of nerandomilast in the body. 

Detailed recommendations for using Jascayd will be published in the summary of product characteristics, which will be available on the EMA website in all official European Union languages once the European Commission has granted the drug marketing authorization. 

Annie Lennon is a medical journalist. Her writing appears on Medscape, WebMD, and Medical News Today, among other outlets.