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AstraZeneca's lung scarring drug gets US FDA orphan drug designation

AstraZeneca PLC said saracatinib was granted orphan drug designation by the U.S. Food and Drug Administration for treating a lung scarring disease.

The U.S. regulator granted the designation to saracatinib for treating idiopathic pulmonary fibrosis, a progressive lung disease that results in the scarring of the lungs — leading to shortness of breath or respiratory failure. The disorder is called idiopathic because of its unknown cause, but AstraZeneca says the cause is thought to be due to an abnormal wound-healing process that causes excessive tissue buildup in the lungs.

U.K.-based AstraZeneca said saracatinib has passed phase 1 development, but phase 2 trials for the therapy have yet to begin. Preclinical trials of the drug showed that it inhibits fibroblast activity and collagen deposition, which characterize lung fibrosis.

The U.S. FDA grants orphan designation to therapies that address rare diseases or disorders that affect below 200,000 people in the U.S. About 100,000 people are affected by IPF in the U.S.