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AZ’s EGPA drug Fasenra receives orphan drug designation
by Eo, Yun-Ho Mar 11, 2024 05:55am
AstraZeneca's antibody drug Fasenra has been designated as an orphan drug in Korea for its eosinophilic granulomatosis indication. The Ministry of Food and Drug Safety announced so through an official orphan drug designation notice on the 7th. More specifically, the drug received an orphan drug designation as a treatment for eosinophilic granulomatosis with polyangiitis (EGPA) Fasenra (benralizumab)’s EGPA indication was granted an orphan drug designation by the US FDA in 2018. AstraZeneca recently presented results from its MANDARA trial at the American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting, showing the drug’s potential. The MANDARA trial is a head-to-head trial that directly compared Fasenra to GSK's antibody drug Nucala (mepolizumab). In the trial, patients with relapsing or refractory EGPA were given one 30mg subcutaneous injection of Fasenra or three 100mg injections of Nucala every four weeks for 52 weeks to compare the efficacy and safety of the two drugs. 140 adults with difficult-to-treat EGPA who were receiving oral corticosteroids, with or without stable immunosuppressive treatment enrolled in the study. The mean age of the patients was 52 years, and 60% were women. Of these patients, 66% had relapsing disease and 60% had refractory disease. Study results showed that the rate of patients who achieved remission at weeks 36 and 48 was 59% in the Fasenra(benralizumab) group and 56% in the Nucala (mepolizumab) group. Although the rate was slightly higher in the Fasenra group compared with the Nucala group, the difference was not statistically significant. However, the results demonstrated Fasenra’s non-inferiority to Nucala. The secondary endpoints, duration of remission and the time to first relapse, were similar in both treatment groups. The mean reductions in blood eosinophil count from baseline to week 52 were comparable between the two groups, the Fasenra group showing reductions from 306.0/µL to 32.4/µL and the Nucala group showing reductions from 384.9/µL to 71.8/µL.1 EGPA is a systemic vasculitis associated with asthma, eosinophilia, sinusitis, pulmonary infiltrates, and neuropathy. EGPA can result in damage to multiple organs, including the lungs, skin, heart, gastrointestinal tract, and nerves, which accumulate over time and can be fatal if left untreated. Fasenra is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis (programmed cell death). Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan, and other countries, and is approved for self-administration in the US, EU, and other countries. In Korea, the drug is being reviewed for reimbursement coverage as a treatment for severe eosinophilic asthma and the agenda has passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee review recently.