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news.AstraZeneca’s respiratory biologic Fasenra (benralizumab) has secured the orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA).
Image: AstraZeneca's Fasenra gets orphan drug designation from FDA for EGPA. Photo: courtesy of Astrazeneca.
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Developed by AstraZeneca with MedImmune, its research and development arm, Fasenra was in-licensed from BioWa, a subsidiary of Japanese pharma company Kyowa Hakko Kirin.
Considered to be a rare autoimmune disease, EGPA, which was previously known as Churg-Strauss Syndrome, can lead to damage to multiple organs and tissues. The disease is characterized by inflammation of blood vessels and the presence of high levels of a type of white blood cell called eosinophils.
EGPA, if left untreated, could turn out to be fatal as per the American Partnership for Eosinophilic Disorders.
According to AstraZeneca, Fasenra has been designed to cause rapid and near-complete depletion of eosinophils in the blood. The respiratory biologic had proved its efficacy in severe, eosinophilic asthma, which indicates that it could benefit patients with EGPA, said the pharma major.
AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “EGPA is a rare, but debilitating inflammatory disease and patients with the disease typically have very high levels of eosinophils.
“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.”
As of now, the company is yet to begin its phase 3 trials for the respiratory biologic in EGPA.
Fasenra, which is a monoclonal antibody, directly binds to IL-5 receptor α on eosinophils and attracts natural killer cells to trigger rapid and near-complete depletion of eosinophils through apoptosis.
In January 2018, the respiratory biologic was approved in Europe as an add-on maintenance treatment for certain type of patients having severe eosinophilic asthma. Prior to that, in November 2017, the AstraZeneca drug was approved in the US as an add-on maintenance treatment for patients with severe asthma, aged 12 years and older, and having an eosinophilic phenotype.
Fasenra is also being evaluated by AstraZeneca for the treatment of severe nasal polyposis.
