EDE approves Jascayd for treating idiopathic pulmonary fibrosis

UAE—The Emirates Drug Establishment (EDE) has granted regulatory approval for Jascayd® (nerandomilast), a therapy indicated for adult patients living with Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF).

The decision expands treatment options for chronic lung disease in the UAE and strengthens access to innovative respiratory medicines across the healthcare system.

The approval follows a detailed scientific and regulatory review conducted by Emirates Drug Establishment, which assessed the product’s quality, safety profile, clinical efficacy, and supporting trial data before granting authorization.

How the treatment works

Jascayd® acts as a selective inhibitor of phosphodiesterase-4B (PDE4B), a biological pathway linked to inflammation and fibrotic processes in the lungs.

By targeting this mechanism, the therapy helps slow the decline in lung function in patients diagnosed with IPF and PPF.

Doctors use it as part of a broader management approach for chronic fibrosing lung conditions, where preserving respiratory capacity remains a central clinical goal.

The treatment is designed for adult patients and is administered under specialist supervision.

Clinical evidence behind approval

The regulatory decision was supported by clinical trial results demonstrating that nerandomilast reduces the rate of lung function decline in patients with progressive fibrotic lung disease.

Researchers observed measurable benefits in stabilizing respiratory performance over time compared to baseline disease progression patterns.

In addition, the EDE reviewed supporting datasets covering safety outcomes, dosing tolerability, and long-term treatment response before concluding that the benefits outweigh the associated risks in eligible patient groups.

A regional first for advanced therapy access

With this approval, the UAE becomes the first country in the region and the third globally, following the United States and China, to authorize Jascayd® for clinical use.

The milestone reflects the country’s continued focus on accelerating access to advanced therapies through an adaptive and science-driven regulatory framework.

It also highlights the UAE’s broader strategy of strengthening pharmaceutical innovation pathways while maintaining alignment with internationally recognized evaluation standards.

Focus on early diagnosis and patient care

Alongside the approval, the Emirates Drug Establishment emphasized the importance of early diagnosis and consistent monitoring for patients with chronic lung diseases.

Early intervention, clinicians note, can help improve treatment response, delay disease progression, and enhance overall quality of life.

Healthcare providers are encouraged to maintain regular follow-up schedules for patients at risk of fibrotic lung conditions, ensuring timely adjustment of therapy where necessary and improving long-term respiratory outcomes.