AstraZeneca Pharma India - receives permission to import and sell Benralizumab (Fasenra) for additional indication

AstraZeneca Pharma India has received regulatory permission to import and sell benralizumab (Fasenra) for an additional indication in the United States. The drug has now been approved for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare, immune-mediated vasculitis that can lead to damage in multiple organs and, if untreated, may be fatal. This approval was granted by the U.S. Food and Drug Administration (FDA) following the results of the MANDARA Phase III trial, which demonstrated that nearly 60% of patients treated with Fasenra achieved remission, comparable to those treated with mepolizumab, the only previously approved EGPA treatment.

The trial also showed that 41% of Fasenra-treated patients were able to fully taper off oral corticosteroids, compared to 26% in the mepolizumab group. Fasenra is administered as a single 30 mg subcutaneous injection every four weeks, offering a convenient treatment option for patients. The safety profile observed in the trial was consistent with the known profile of the drug.

This approval expands Fasenra’s existing indications, which include severe eosinophilic asthma in over 80 countries. The FDA had previously granted Orphan Drug Designation for Fasenra for EGPA in 2018.