Saudi Arabia Approves Jascayd for Rare Lung Disease

The Saudi Food and Drug Authority has approved the registration of Jascayd, or nerandomilast, for adults with idiopathic pulmonary fibrosis, a rare progressive disease that causes scarring of lung tissue and declining respiratory function. The drug had previously received Orphan Drug designation under the authority’s programme for treatments targeting rare diseases.

Approval followed an assessment of the drug’s efficacy, safety and quality, including results from the 52-week Phase 3 FIBRONEER-IPF trial involving 1,177 adults. The decline in forced vital capacity was 115 mL among patients receiving 18 mg twice daily and 139 mL for those receiving 9 mg twice daily, compared with 184 mL in the placebo group. Both doses produced a statistically significant reduction in lung-function decline.

Jascayd is a phosphodiesterase 4 inhibitor that preferentially targets the PDE4B subtype, which is involved in fibrosis and inflammation in the lungs. The SFDA listed diarrhoea, nausea, weight loss, decreased appetite and back pain among the most commonly reported adverse reactions, and said treatment should be used under medical supervision in accordance with the approved product information.