«الغذاء والدواء» تعتمد «جاسكايد» لعلاج التليف الرئوي لدى البالغين

The Saudi Food and Drug Authority has approved the registration of the product "Jaskeid" (Nerandomilast), which has previously been designated as an orphan drug under the orphan drug program, for the treatment of adult patients with idiopathic pulmonary fibrosis, a rare lung disease characterized by the gradual accumulation of fibrotic scar tissue in the lungs for unknown reasons, leading to shortness of breath and persistent cough.
The authority explained that the product "Jaskeid" belongs to phosphodiesterase type 4 inhibitors and is characterized by a preferential effect on the subtype 4 (PDE4B), which is present in the lungs and plays an important role in the processes of lung fibrosis and inflammation. By inhibiting (PDE4B), the product works to increase levels of "cyclic adenosine monophosphate" within cells and reduce the expression of fibrosis-stimulating growth factors and inflammatory cytokines that are elevated in patients with idiopathic pulmonary fibrosis.
It added that the approval of the product came after a comprehensive evaluation of its efficacy, safety, and quality, following a pivotal phase three study (FIBRONEER-IPF) that included (1,177) patients with idiopathic pulmonary fibrosis, who were randomly assigned to receive "Jaskeid" at a dose of (9) mg twice daily, or (18) mg twice daily, or a placebo for (52) weeks. At week (52), the average decline in forced vital capacity (FVC) was (115) ml in the "Jaskeid" group at a dose of (18) mg, and (139) ml in the (9) mg group, compared to (184) ml in the placebo group, with the difference compared to the placebo being (69) ml for the (18) mg dose and (45) ml for the (9) mg dose, with both doses achieving a statistically significant reduction in the decline of lung function.
These results support a previous phase two study that included (147) patients with idiopathic pulmonary fibrosis, which showed positive effects of the product at a dose of (18) mg twice daily on (FVC), compared to the placebo after (12) weeks, noting that the most common side effects included diarrhea, nausea, loss of appetite and weight, and back pain. The use of the product requires medical supervision according to the approved leaflet.
The orphan drug program is concerned with supporting the development and registration of products aimed at treating rare diseases and conditions with limited treatment options, as it contributes to accelerating access to targeted therapies and expanding the range of treatment options, in line with the objectives of the health sector transformation program, one of the programs of Saudi Vision 2030.