FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

AstraZeneca Wins Orphan Status for Lung Disease Treatment

March 26, 2019
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The FDA granted orphan status to AstraZeneca’s experimental drug saracatinib for treatment of idiopathic pulmonary fibrosis (IPF), an often fatal lung disease that affects about 100,000 Americans.

Saracatinib (AZD0530) has been in trials ranging from treatment of pancreatic cancer to Alzheimer’s disease to alcohol drinking. AstraZeneca has just added IPF to its respiratory portfolio and says the treatment has shown promise in pre-clinical and Phase I trials.

The company said it plans to take saracatinib into Phase II trials soon.

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