01 Dec FDA Grants Orphan Drug Designation For Eosinophilic Granulomatosis with Polyangiitis
MedicalResearch.com Interview with:
Mr. Tosh Butt
Vice President, Respiratory
Mr. Butt discusses the recent announcement that the FDA has granted Orphan Drug Designation for Fasenra for the treatment of Eosinophilic Granulomatosis with Polyangiitis.
MedicalResearch.com: What is the background for this announcement? Can you tell us a little more about Eosinophilic Granulomatosis with Polyangiitis/Churg Strauss? How does it differ/resemble severe eosinophilic asthma?
- The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for FASENRA™ (benralizumab) for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA). The ODD application was based on epidemiology demonstrating the rarity of the disease (<200k US patients) and a scientific rationale that FASENRA may benefit patients with this condition. The core role of eosinophilia in EGPA and FASENRA’s demonstrated eosinophil-depleting properties provided this rationale and suggest it may deliver benefit to patients with EGPA.
- EGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues. EGPA is characterized by inflammation of blood vessels and the presence of elevated levels of eosinophils, a type of white blood cell. All patients with EGPA have very high levels of eosinophils at some point in their disease. FASENRA induces rapid and near-complete depletion of eosinophils in the blood and has proven efficacy in severe eosinophilic asthma, which suggest it may deliver benefit to patients with EGPA.
MedicalResearch.com: How does benralizumab differ from other treatments for Eosinophilic Granulomatosis with Polyangiitis?
Response: FASENRA is the only respiratory biologic that binds directly to IL-5 receptor α on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death). FASENRA has a strong clinical profile in severe eosinophilic asthma, and we believe that FASENRA could provide benefit to patients in diseases in which eosinophils play a role.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: No specific studies have been completed of FASENRA for the treatment of EGPA. AstraZeneca is currently collaborating on a non-comparative, open-label, investigator-sponsored study (NCT03010436).
MedicalResearch.com: Is there anything else you would like to add?
Response: AstraZeneca is exploring FASENRA’s potential to address unmet medical needs in other eosinophil-driven diseases. We will share additional plans in due course.
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Last Updated on December 1, 2018 by Marie Benz MD FAAD