Dubai: The Emirates Drug Establishment (EDE) has granted regulatory approval for Jascayd® (nerandomilast), a treatment prescribed for Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) in adult patients. This decision is expected to enhance access to advanced therapies and support the progress of healthcare standards in the region.
According to Emirates News Agency, Jascayd® is an innovative therapy that functions through the selective inhibition of phosphodiesterase-4B (PDE4B). It aims to slow the decline in lung function for patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF).
The approval of Jascayd® followed a thorough scientific and regulatory assessment carried out by the EDE. This process included a review of the product's quality, safety, efficacy, and supporting clinical data. The decision was based on clinical study results that demonstrated the treatment's capability to reduce the rate of lung function decline in patients with these conditions.
With this approval, the UAE becomes the first country in the region and the third globally, after the United States and China, to approve this treatment. This milestone underscores the efficiency of the UAE's regulatory framework and its capacity to expedite the evaluation and approval of pharmaceutical innovations in accordance with internationally recognised scientific standards.
The Emirates Drug Establishment highlighted the significance of early diagnosis and regular follow-up for patients with chronic lung diseases. These practices are essential for supporting timely therapeutic interventions, improving health outcomes, and enhancing the quality of life for affected individuals.