The U.S. Food and Drug Administration (FDA) has approved Jascayd (nerandomilast) tablets for the treatment of patients with idiopathic pulmonary fibrosis (IPF). This is the first new therapy to be approved in this indication for 10 years.
IPF is a rare, progressive disorder characterized by the progressive scarring of tissues in the lungs. Common symptoms include shortness of breath and a dry, hacking cough. In some cases fibrosis happens quickly, while in others, the process is slower. The cause of IPF is unknown. It is most often diagnosed in patients aged 60 to 70 years.
Nerandomilast is an inhibitor of phosphodiesterase 4B with antifibrotic and immunomodulatory effects. It has an orphan drug indication for treating patients with ITP. The drug also secured Priority Review and Breakthrough Therapy Designation from the FDA.
This approval follows positive data from two randomized, double-blind, placebo controlled trials in adults with IPF. The primary endpoint was absolute change from baseline in Forced Vital Capacity (FVC). Patients on nerandomilast tablets demonstrated a significantly smaller FVC decline compared to those on placebo.
The most common side effects are diarrhea, COVID-19, upper respiratory tract infection, depression, decrease in weight, decreased appetite, nausea, fatigue, headache, vomiting, back pain, and dizziness.
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To learn more about IPF and other rare lung conditions, visit https://checkrare.com/diseases/lung-diseases/