The US Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for AstraZeneca‘s saracatinib, a potential new medicine for the treatment of idiopathic pulmonary fibrosis a rare type of lung disease that results in scarring of the lungs.
IPF is a chronic, progressive, irreversible and usually fatal lung disease which affects approximately 100,000 people in the US.
On average, patients who are diagnosed with IPF live between two and five years from diagnosis, given the limited medicines available to treat the disease.
The FDA grants orphan drug status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.
Mene Pangalos, executive vice president, R&D BioPharmaceuticals, said: “Idiopathic pulmonary fibrosis has a significant impact on patients’ lives and new therapies are urgently needed. IPF is a recent addition to our respiratory research strategy and we are interested to see whether saracatinib could be a useful approach for the treatment of this intractable disease.”
IPF is characterized by thickening and scarring of the connective (interstitial) tissue in the lungs. The cause is thought to be due to an abnormal wound-healing process that results in excessive tissue build-up in the lung.
IPF causes shortness of breath and progressive damage of the lung, resulting in life-threatening complications such as respiratory failure.
AstraZeneca employs 1,500 in northern Delaware.
