AstraZeneca’s FASENRA (benralizumab) has received FDA approval for treating adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune vasculitis that affects various organs and can be life-threatening if left untreated.
The approval stems from the positive results of the MANDARA Phase III trial, where FASENRA demonstrated comparable efficacy to mepolizumab, the only previously approved treatment for EGPA. In the trial, nearly 60% of patients treated with FASENRA achieved remission, a crucial goal in treating EGPA.
Moreover, FASENRA showed a substantial benefit in reducing oral corticosteroid (OCS) dependence. Notably, 41% of patients fully discontinued OCS use, compared to 26% in the mepolizumab group. This finding is significant as long-term OCS use carries severe side effects.
EGPA often coexists with adult-onset severe eosinophilic asthma (SEA), and FASENRA is now the second biologic approved for both conditions. It is currently used as a maintenance treatment for SEA in many countries and is also approved for children and adolescents over the age of six.
The FDA’s Orphan Drug Designation for FASENRA in EGPA highlights its potential to address a rare and challenging disease. With its convenient monthly subcutaneous injection, FASENRA provides a promising new treatment option for EGPA patients, offering the hope of achieving remission and reducing steroid dependency.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
