Fasenra (benralizumab) for Eosinophilic Esophagitis was made a reality today, when the FDA granted it Orphan Drug Designation (ODD). The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”).
Eosinophilic Esophagitis is a rare, chronic inflammatory disease that occurs when eosinophils, which a type of allergic white blood cell, accumulates in ones esophagus causing injury and inflammation. The disease results in injury, fibrosis and dysfunction that is not easily treated. Symptoms can range from eating difficulty, food getting stuck, acid reflux, leading to chronic pain, difficulty swallowing, poor growth, malnutrition and weight loss. The most common symptoms of EoE include reflux that does not respond to acid blockers (Zantac) or proton pump inhibitors.
In previous posts, we have discussed EoE extensively and the various treatment options available.
Fasenra (benralizumab) was approved initially for add-on maintenance therapy in severe eosinophilic asthma. Fasenra is a monoclonal antibody that is injected and it binds directly to the IL-5 receptor alpha on eosinophils and it results in programmed cell death, resulting in rapid and near-complete depletion of eosinophils.
Besides Fasenra for Eosinophilic Esophagitis, it is currently in development for severe nasal polyps, eosinophilic granulomatosis with polyangitis, hypereosinophilic syndrome and chronic obstructive pulmonary disease (COPD).
Fasenra is currently dosed for asthma with a 30mg pre-filled syringe, that is given subcutaneously every 4 weeks for the first 3 months. Thereafter, it is given every 8 weeks. Earlier this year it was announced that Fasenra will have an auto-injector pen available, that patients can self administer at home.