Saudi FDA approves Jaskaide for idiopathic pulmonary fibrosis in adults

The Saudi Food and Drug Authority has approved the registration of Jaskaide (Nirandomilast) for the treatment of adult patients with idiopathic pulmonary fibrosis, a rare lung disease in which scar tissue gradually accumulates in the lungs without a known cause, leading to shortness of breath and persistent cough.

The authority explained that Jaskaide is a phosphodiesterase type 4 inhibitor, with a preferential effect on the PDE4B subtype, an enzyme found in the lungs that plays a key role in lung fibrosis and inflammation. By inhibiting PDE4B, the drug increases intracellular cyclic adenosine monophosphate (cAMP) levels and reduces the expression of pro-fibrotic growth factors and inflammatory cytokines, which are elevated in patients with idiopathic pulmonary fibrosis.

The approval followed a comprehensive evaluation of the drug’s efficacy, safety, and quality. The pivotal phase 3 FIBRONEER-IPF study included 1,177 patients with idiopathic pulmonary fibrosis, who were randomly assigned to receive Jaskaide at 9 mg twice daily, 18 mg twice daily, or placebo for 52 weeks. At week 52, the mean decline in forced vital capacity (FVC) was 115 ml in the 18 mg group and 139 ml in the 9 mg group, compared to 184 ml in the placebo group. The difference versus placebo was 69 ml for the 18 mg dose and 45 ml for the 9 mg dose, with both doses showing a statistically significant reduction in the rate of lung function decline.

These results were supported by a previous phase 2 study involving 147 patients with idiopathic pulmonary fibrosis, which showed a positive effect of the 18 mg twice-daily dose on FVC compared to placebo after 12 weeks. The most common side effects included diarrhea, nausea, loss of appetite, weight loss, and back pain. The authority noted that use of the drug requires medical supervision according to the approved prescribing information.

The Orphan Drug Program supports the development and registration of treatments for rare diseases and conditions with limited therapeutic options, helping to accelerate access to specialized therapies and expand treatment choices in line with the Health Sector Transformation Program, part of Saudi Vision 2030.