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FDA grants orphan drug designation to AstraZeneca\'s \'saracatinib\'

By Josh White

Date: Monday 18 Mar 2019

FDA grants orphan drug designation to AstraZeneca\'s \'saracatinib\'

(Sharecast News) - AstraZeneca announced on Monday that the US Food and Drug Administration (FDA) has granted \'orphan drug designation\' for \'saracatinib\' - a potential new medicine for the treatment of idiopathic pulmonary fibrosis (IPF).
The FTSE 100 pharmaceuticals giant described IPF as a type of lung disease that resulted in scarring - or fibrosis - of the lungs.

It said saracatinib was an inhibitor of src kinase, which regulates broad cell functions including cell growth and cell differentiation, and had completed phase I development.

AstraZeneca said IPF is a \"chronic, progressive, irreversible and usually fatal\" interstitial lung disease, which affected approximately 100,000 people in the US.

On average, patients who were diagnosed with IPF lived between two and five years from diagnosis, given the limited medicines available to treat the disease.

The FDA grants orphan drug designation status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affected fewer than 200,000 people in the US.

\"Idiopathic pulmonary fibrosis has a significant impact on patients\' lives and new therapies are urgently needed,\" said Mene Pangalos, AstraZeneca\'s executive vice-president of biopharmaceuticals research and development.

\"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.\"

The firm said IPF was characterised by thickening and scarring of the connective tissue in the lungs.

It said the cause was thought to be due to an abnormal wound-healing process that resulted in excessive tissue build-up in the lung.

Preclinical trials of saracatinib reportedly showed that it inhibited fibroblast activity and collagen deposition, which were key features of lung fibrosis.


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