NATIONAL JEWISH HEALTH

AstraZeneca's Fasenra approved in the US for EGPA, based on MANDARA trial results showing efficacy vs. mepolizumab. Fasenra offers a new treatment option, potentially reducing steroid dependency.

FDA approves Fasenra (benralizumab) for EGPA, based on MANDARA trial showing it as effective as Nucala in inducing remission and reducing steroid use. Fasenra, developed by AstraZeneca, is administered monthly via subcutaneous injection and is priced at $5,511.41 per dose, with average out-of-pocket cost of $46 for insured patients.

The FDA approved AstraZeneca’s Fasenra for EGPA, based on the MANDARA trial showing its efficacy compared to Nucala. Fasenra helped 60% of patients achieve remission and 41% taper off OCS, with safety comparable to Nucala. This approval offers a new treatment option for the 15,000 US EGPA patients.

The FDA approved AstraZeneca’s benralizumab (Fasenra) for adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), based on the MANDARA phase 3 trial. The study showed benralizumab was noninferior to mepolizumab in achieving remission and allowed more patients to taper off corticosteroids. Benralizumab is now indicated for EGPA treatment, with a recommended dose of 30 mg every 4 weeks.

The FDA has approved benralizumab (Fasenra) for eosinophilic granulomatosis with polyangiitis (EGPA) in adults, making it the second treatment option in the US. The approval was based on the phase 3 MANDARA trial, which showed benralizumab achieved remission and allowed steroid tapering in EGPA patients. The therapy's safety profile was consistent with previous findings.

AstraZeneca's FASENRA® (benralizumab) approved in the US for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). Approval based on MANDARA Phase III trial results, showing FASENRA's efficacy and safety comparable to mepolizumab. FASENRA helps patients achieve remission and taper off oral corticosteroids.

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis; MANDARA trial showed nearly 60% of patients achieved remission and 41% fully stopped taking oral corticosteroids.