According to a story from Check Orphan, the biopharmaceutical company AstraZeneca recently announced that its drug benralizumab (marketed as Fasenra) has earned Orphan Drug designation from the US Food and Drug Administration (FDA). This designation is for the use of the drug as a treatment for eosinophilic esophagitis, a rare disease. The designation could indicate that Fasenra could ultimately be approved for this use in the future.
About Eosinophilic Esophagitis
Eosinophilic esophagitis (EoE), is a condition in which the esophagus become inflamed due to an allergic reaction that involves the activity of eosinophils, a form of white blood cell. Generally, the allergic reaction is triggered by some type of food that the patient has eaten, but it is often difficult to determine which specific food item is the cause. Symptoms of eosinophilic esophagitis include difficulty swallowing, nausea, painful swallowing, heartburn, rings in the esophagus, narrowing of the esophagus, blockage of the esophagus, and vomiting. Current treatments involve medication to suppress the immune response, eliminating known food allergens, and expanding the esophagus. Many people with the condition also have other autoimmune problems, such as celiac disease or asthma. To learn more about eosinophilic esophagitis, click here.
About Orphan Drug Designation
Orphan Drug designation is typically reserved for therapies that are intended to treat diseases that are considered rare, which is defined as any illness that affects less than 200,000 people in the US. To qualify, a drug must display potential advantages in efficacy or safety over current therapies. Alternatively, it must fulfill a currently unmet medical need. Orphan Drug designation confers several benefits to the recipient company, such as tax breaks, the waiving of certain fees, and a period of market exclusivity lasting seven years if the drug is approved by the FDA.
About Fasenra
Fasenra is the first biologic medicine developed by AstraZeneca for respiratory conditions. It is currently approved as a supplementary maintenance treatment for patients with eosinophilic asthma in much of the world. The drug has also earned Orphan Drug designation for other diseases as well, such as hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis. The mechanism of action causes the depletion of eosinophils, meaning that Fasenra has potential efficacy in any diseases where these cells play a significant role.
