AstraZeneca PLC said the U.S. Food and Drug Administration granted orphan drug status to Fasenra for treating a rare esophagus disease.
Fasenra, or benralizumab, was awarded the designation to treat patients with eosinophilic esophagitis, a rare, chronic, inflammatory disease of the esophagus that can lead to chronic pain, difficulty in swallowing, malnutrition and weight loss.
The U.S. regulator awards orphan drug designation to medicines that treat diseases that affect fewer than 200,000 people in the country.
There are no FDA-approved treatments for eosinophilic oesophagitis.
Fasenra won orphan drug status from the FDA in 2018 to treat eosinophilic granulomatosis with polyangiitis, a rare autoimmune disease that causes inflammation of blood vessels in the nose, lungs, kidneys and other organs.
In February, the FDA also granted Fasenra the same designation for treating hypereosinophilic syndrome, a group of rare disorders categorized by a high number of a type of white blood cell called eosinophils eosinophils, which affects the immune system.
Fasenra is approved as an add-on maintenance treatment for patients with severe, eosinophilic asthma — an asthma subtype that is commonly seen in people who develop the disease in adulthood — in the U.S., EU, Japan and other jurisdictions.
