SFDA Approves Registration of "Jascayd" for the Treatment of Idiopathic Pulmonary Fibrosis

The Saudi Food and Drug Authority (SFDA) has approved the registration of Jascayd (nerandomilast) for the treatment of adult patients with idiopathic pulmonary fibrosis (IPF). The drug was previously granted Orphan Drug designation under the SFDA Orphan Drug Program.

Idiopathic pulmonary fibrosis (IPF) is a rare, progressive lung disease characterized by the continuous formation of fibrous scar tissue in the lungs. This scarring replaces healthy lung tissue, leading to severe shortness of breath and persistent cough.

Innovative Mechanism of Action

Jascayd is a phosphodiesterase 4 (PDE4) inhibitor with preferential inhibition of the PDE4B subtype. This enzyme is found in the lungs and plays an important role in fibrosis and inflammation. By blocking PDE4B, it increases intracellular cAMP levels and reduces the expression of pro-fibrotic growth factors and inflammatory cytokines, which are known to be overexpressed in patients with IPF.

Positive Results Demonstrated in Clinical Studies

Approval was granted following a comprehensive evaluation of the drug’s efficacy, safety, and quality by the SFDA.

In the pivotal Phase 3 FIBRONEER-IPF trial, 1,177 patients with IPF were randomized to receive Jascayd 9 mg twice daily, Jascayd 18 mg twice daily, or placebo over 52 weeks. The decline in forced vital capacity (FVC) was 115 mL with Jascayd 18 mg and 139 mL with Jascayd 9 mg, compared with 184 mL in placebo. The estimated treatment differences versus placebo were 69 mL and 45 mL, respectively. Both doses demonstrated a statistically significant reduction in FVC decline compared with placebo.

These findings were supported by an earlier Phase 2 study in 147 patients with IPF, in which Jascayd 18 mg twice daily demonstrated a favorable effect on FVC compared with placebo after 12 weeks.

Most Common Side Effects

The SFDA noted that the most commonly reported adverse reactions included diarrhea, nausea, weight loss, decreased appetite and back pain. Treatment should be used under medical supervision in accordance with the approved product information.

A New Step Toward Enhancing the Quality of Healthcare

This approval reflects the SFDA’s continued commitment to innovation and expanding access to advanced treatment options, thereby enhancing the quality of healthcare in alignment with the goals of the Health Sector Transformation Program, one of the key initiatives of Saudi Vision 2030.

SFDA Orphan Drug Program Accelerates Access to Specialized Therapies

This approval underscores the SFDA's strategic commitment to advancing patient access to therapies for rare diseases through the Orphan Drug Program. By facilitating the availability of specialized treatments and addressing unmet medical needs, the program contributes to enhancing the quality of healthcare in the Kingdom, in alignment with the objectives of the Health Sector Transformation Program, one of the key initiatives of Saudi Vision 2030.

For further details, please refer to the SFDA Guidance for Orphan Drug Designation at: https://www.sfda.gov.sa/en/guide/guidance-orphan-drug-designation