FDA Grants Orphan Drug Designation For Eosinophilic Granulomatosis with Polyangiitis

MedicalResearch.com Interview with:

Mr. Tosh Butt Vice President, Respiratory AstraZeneca

Mr. Butt

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. 

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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