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 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 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 approved for treatment of children aged 6 to 11 ...
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 ...
Fasenra approved in the US for eosinophilic granulomatosis with ...
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
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...
AZ's Fasenra shows comparable efficacy in trial vs. GSK's Nucala
Sep 12, 2023 · AstraZeneca's Fasenra has demonstrated noninferiority in remission in a head-to-head battle against GSK's Nucala in patients with EGPA.
New Fasenra data from the MELTEMI extension trial confirm long …
May 19, 2021 · Results from a new integrated analysis including data from the MELTEMI Phase III open-label extension trial showed Fasenra (benralizumab) was well-tolerated for up to five years, with a long-term safety profile consistent with previous Phase III trials in adult patients with severe asthma. 1. Results were presented today at the American ...
Fasenra Approved in the US for Eosinophilic Granulomatosis with ...
AstraZeneca news release. Fasenra met the primary endpoint in the MANDARA Phase III trial in eosinophilic granulomatosis with polyangiitis (EGPA).
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).