AstraZeneca Secures FDA Approval for Fasenra in Rare Autoimmune Disorder EGPA

FDA Approval:
The FDA has approved AstraZeneca's Fasenra (benralizumab) for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disorder.

Clinical Trial Results:
The approval is based on the phase III MANDARA trial, which showed that Fasenra achieved a 59% remission rate, comparable to GSK's Nucala (mepolizumab) at 56%.

Dosing Regimen:
Fasenra is administered as a single 30-mg subcutaneous injection every four weeks, offering a more convenient dosing regimen compared to Nucala.

Market Impact:
This new indication is expected to enhance Fasenra's sales, which have been bolstered by robust demand and an expanding market share. Fasenra generated $781 million in sales in the first half of 2024, representing a 6% year-over-year increase.

Competitive Landscape:
Fasenra competes with other biologics in the asthma space, including Regeneron and Sanofi's Dupixent (dupilumab) and GSK's Nucala.