AstraZeneca’s Fasenra meets primary endpoint in MANDARA Phase 3 trial for EGPA
AstraZeneca’s Fasenra met its primary endpoint in the MANDARA Phase III trial, offering a monthly treatment option for eosinophilic granulomatosis with polyangiitis (EGPA) patients. Fasenra demonstrated non-inferior remission rates compared to the thrice-a-month injections of mepolizumab, which is currently the only approved EGPA treatment.
Fasenra vs. Mepolizumab: A Close Comparison in EGPA Treatment
The MANDARA trial is groundbreaking as the first head-to-head Phase III comparison between biologics for EGPA. Participants were randomized to receive either a single 30mg subcutaneous injection of Fasenra or three separate 100mg injections of mepolizumab once every four weeks. The primary endpoint measured the proportion of patients in remission at weeks 36 and 48. The safety profile of Fasenra was consistent with its known medical profile.
AstraZeneca’s Fasenra Demonstrates Non-Inferiority in EGPA Trial. Photo courtesy of D Wells/Wikimedia Commons.
EGPA: A Serious, Rare Condition
EGPA is an immune-mediated vasculitis affecting small to medium-sized blood vessels, leading to potential damage to various organs. Approximately half of the EGPA patients also suffer from adult-onset severe eosinophilic asthma. Without adequate treatment, the condition could result in fatalities.
Expert Opinions on MANDARA Trial Results
Dr Michael Wechsler, the Principal Investigator, said, “The positive MANDARA trial results are exciting because patients with eosinophilic granulomatosis with polyangiitis today have limited treatment options but face crippling symptoms, which can even be fatal if not treated.” Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, added, “The positive results from MANDARA demonstrate that Fasenra can help patients achieve remission from the debilitating impacts of this inflammatory disease with a more convenient single monthly subcutaneous injection.”
Fasenra Mechanism and Future Prospects
Fasenra, a monoclonal antibody, targets IL-5 receptor alpha on eosinophils. It is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in several countries. Fasenra is also under exploration for treating other eosinophil-related conditions.
Ongoing Research and Regulatory Approvals
Full results from the MANDARA Phase III trial will be presented at upcoming medical conferences and shared with global health authorities. The FDA granted Orphan Drug Designation for Fasenra for EGPA in 2018, and AstraZeneca continues to investigate its broader applications.
The trial was a 52-week, double-blind, active-controlled, multicenter study involving 140 adult patients. All patients completing the 52-week double-blind period may continue into an open-label extension with Fasenra.