FDA Grants Fasenra Orphan Drug Designation for Rare Inflammatory Disease

AstraZeneca reported on November 26, 2018, that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its drug Fasenra (benralizumab) for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA).

EGPA is a rare autoimmune condition that can affect multiple organs. The FDA's ODD status is given to medicines intended to treat, diagnose, or prevent rare diseases or disorders affecting fewer than 200,000 people in the US.

"EGPA is a rare, but debilitating inflammatory disease, and patients with the disease typically have very high levels of eosinophils," said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca. "Our clinical trials for Fasenra in severe, eosinophilic asthma show it depletes eosinophils, and we are exploring the potential of this medicine to address unmet medical needs in other eosinophil-driven diseases."

EGPA is characterized by blood vessel inflammation and elevated levels of eosinophils, a type of white blood cell. Fasenra rapidly and nearly completely depletes eosinophils in the blood. The drug has demonstrated efficacy in severe, eosinophilic asthma, suggesting potential benefits for EGPA patients. Fasenra is AstraZeneca's first respiratory biologic medicine and is currently approved as an add-on treatment for severe, eosinophilic asthma in the US, EU, and Japan.