Riyadh:The Saudi Food and Drug Authority (SFDA) has approved the registration of Jascayd (nerandomilast) as a treatment for adult patients with idiopathic pulmonary fibrosis (IPF). This progressive lung disease is marked by the formation of fibrous scar tissue, leading to severe breathing difficulties and persistent coughing.

According to Saudi Press Agency, Jascayd was previously designated as an Orphan Drug under the SFDA Orphan Drug Program. The drug functions as a phosphodiesterase 4 (PDE4) inhibitor, specifically targeting the PDE4B subtype found in the lungs. By inhibiting this enzyme, Jascayd increases intracellular cAMP levels and reduces the expression of pro-fibrotic growth factors and inflammatory cytokines, which are typically overexpressed in IPF patients.

The SFDA granted approval following a thorough evaluation of Jascayd's efficacy, safety, and quality. The pivotal Phase 3 FIBRONEER-IPF trial involved 1,177 patients who were administered either Jascayd 9 mg, Jascayd 18 mg, or a placebo over 52 weeks. Results showed a notable reduction in the decline of forced vital capacity (FVC) for patients taking Jascayd compared to those receiving the placebo.

These Phase 3 findings were supported by an earlier Phase 2 study, which also demonstrated a favorable effect of Jascayd on FVC. Common side effects reported included diarrhea, nausea, weight loss, decreased appetite, and back pain. The SFDA advises that Jascayd should be used under medical supervision According to approved product information.

This approval underscores the SFDA's commitment to advancing healthcare and expanding access to innovative treatment options, consistent with the goals of Saudi Vision 2030's Health Sector Transformation Program.