FASENRA approved in the US for eosinophilic granulomatosis with ...
WEBSep 18, 2024 · New indication supported by the MANDARA trial which showed nearly 60% of patientsachieved remission and 41% of patients fully stopped taking oral corticosteroids. 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 …
CHMP Endorses AstraZeneca's Fasenra in Rare Autoimmune Disease
WEB7 hours ago · Image Source: Zacks Investment Research. Fasenra – A Key Top-line Driver for AZN. Fasenra is currently approved in more than 80 countries across the world, including the United States, European ...
Fasenra recommended for approval in the EU by CHMP for the …
WEB1 day ago · With over 15 years of clinical data, Fasenra is a well-established, leading treatment for severe eosinophilic asthma, and now has the potential to transform care for patients with EGPA. Today’s news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma.”
EMA CHMP recommends AstraZeneca’s Fasenra to treat EGPA
WEB1 day ago · The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approving AstraZeneca’s Fasenra (benralizumab) to treat adults with relapsing or ...
FDA Approves Fasenra for Eosinophilic Granulomatosis With …
WEB8 hours ago · Fasenra is supplied in single-dose prefilled syringes (10mg/0.5mL, 30mg/mL) and in single-dose autoinjector pens (30mg/mL). In EGPA, the recommended dosage is 30mg SC administered every 4 weeks.
FASENRA approved in the US for eosinophilic granulomatosis with ...
WEB6 days ago · The safety and tolerability profile for FASENRA in the MANDARA trial was consistent with the known profile of the medicine. 4 Approximately half of patients with EGPA have adult-onset severe ...
FASENRA met the primary endpoint in the MANDARA Phase III …
WEBSep 11, 2023 · FASENRA to three injections per month of mepolizumab. 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 …
Fasenra met the primary endpoint in the MANDARA Phase III trial …
WEBSep 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 ...
AstraZeneca: Fasenra Approved By FDA To Treat Eosinophilic ...
WEB6 days ago · Fasenra is currently approved as an add-on maintenance treatment for SEA in more than 80 countries including the US, Japan, EU and China. It is also approved in children and adolescents ages six ...
Fasenra - opinion on variation to marketing authorisation
WEB6 days ago · On 19 September 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Fasenra. The marketing authorisation holder for this medicinal product is AstraZeneca AB. The CHMP adopted an extension to the existing indication as follows: Eosinophilic granulomatosis with ...