FASENRA approved in the US for eosinophilic granulomatosis …
Sep 18, 2024 — AstraZeneca’s FASENRA ® (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 1 EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal. 2,3.
Fasenra recommended for approval in the EU by CHMP for the …
Sep 23, 2024 — New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids. AstraZeneca’s Fasenra (benralizumab) has been recommended for approval in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory ...
Fasenra met the primary endpoint in the MANDARA Phase III trial …
Sep 11, 2023 — Positive high-level results from the MANDARA Phase III trial showed AstraZeneca’s Fasenra (benralizumab) met the primary endpoint of the trial and demonstrated non-inferior rates of remission compared to mepolizumab in patients with eosinophilic granulomatosis with polyangiitis (EGPA) who were receiving oral corticosteroids (OCS) with or ...
FASENRA met the primary endpoint in the MANDARA Phase III …
Sep 11, 2023 — MANDARA is the first Phase III head-to-head trial of biologics in EGPA and compared the efficacy and safety of FASENRA versus mepolizumab, the only currently approved treatment. 1,2 In the blinded trial, patients were randomized to receive either a single 30mg subcutaneous injection of FASENRA or three separate 100mg subcutaneous injections of ...
FDA Approves Fasenra for Eosinophilic Granulomatosis With …
Sep 24, 2024 — The Food and Drug Administration (FDA) has approved Fasenra ® (benralizumab) for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
FASENRA approved for treatment of children aged 6 to 11 with …
WILMINGTON, Del., April 11, 2024 -- (BUSINESS WIRE)--AstraZeneca’s FASENRA ® (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for...
FASENRA approved in the US for eosinophilic ... - Morningstar
Sep 18, 2024 — AstraZeneca’s FASENRA ® (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 1 EGPA is a rare, immune-mediated...
AZN Gets FDA Nod for Fasenra Label Expansion in Rare Disease
Sep 18, 2024 — 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...
Fasenra approved in the EU for eosinophilic granulomatosis with ...
Oct 28, 2024 — AstraZeneca’s Fasenra (benralizumab) has been approved in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).
FASENRA approved for treatment of children aged 6 to 11 with …
Apr 11, 2024 — AstraZeneca’s FASENRA ® (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype. 1 FASENRA was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma (SEA) in patients aged ...