Fasenra (benralizumab)
- Region
- 🇪🇺 EU
- Active substance
- benralizumab
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- Asthma
- CHMP opinion
- Thu 09 Nov 2017
- EU approval
- Mon 08 Jan 2018
- Application
- EMEA/H/C/004433
- ATC
- R03DX10
- Official record
- www.ema.europa.eu
Indication
AsthmaFasenra is indicated as an add on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long acting β agonists (see section 5.1).Eosinophilic granulomatosis with polyangiitis (EGPA) Fasenra is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis. Hypereosinophilic syndrome (HES) Fasenra is indicated as an add on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.