AstraZeneca AZN announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving the regulatory filing seeking label expansion in the EU for its blockbuster asthma drug Fasenra (benralizumab) in eosinophilic granulomatosis with polyangiitis (EGPA) indication.

AstraZeneca’s Fasenra (benralizumab) met its primary endpoint in the MANDARA trial by demonstrating non-inferiority to the current standard of care, GSK’s Nucala (mepolizumab), in patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Fasenra (benralizumab) has been approved by the US Food and Drug Administration (FDA) to treat adults with eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated inflammatory disease affecting approximately 15,

Before the FDA approved AstraZeneca’s Fasenra, Nucala was the only therapy for treating eosinophilic granulomatosis with polyangiitis.

AstraZeneca AZN announced that the FDA has approved its marketed asthma drug, Fasenra (benralizumab) for a new indication. The regulatory body has now approved Fasenra for treating adult patients with eosinophilic granulomatosis with polyangiitis (“EGPA”).