Fasenra
Authorised
This medicine is authorised for use in the European Union
benralizumab
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Fasenra is a medicine used to treat:
- a particular type of asthma called eosinophilic asthma. It is used as an additional treatment in adults with severe asthma that is not adequately controlled by a combination of high-dose inhaled corticosteroids plus medicines called long-acting beta-agonists;
- eosinophilic granulomatosis with polyangiitis (EGPA) in adults. EGPA is a disease that causes vasculitis (inflammation of blood vessels) in the lungs, heart, intestines, and nerves. This can lead to asthma, chronic sinusitis and elevated levels of a type of white blood cell called eosinophils. It is used with other medicines for EGPA, when the disease has come back or has not responded to previous treatments;
- hypereosinophilic syndrome (HES), a disease in which eosinophils start growing out of control. It is used with other medicines in people aged 12 years and older weighing at least 35 kg. It is used when the disease is not well controlled with previous treatments and when the disease is linked to a blood abnormality or has no obvious cause.
Fasenra contains the active substance benralizumab.
Fasenra is available as a solution for injection in pre-filled syringes and pre-filled pens. It can only be obtained with a prescription and treatment should be started by doctors with experience in the diagnosis and treatment of the conditions Fasenra is used to treat.
Fasenra is injected under the skin of the thighs or belly; if the injection is given by a doctor or carer, it can also be given under the skin of the upper arm.
For the treatment of eosinophilic asthma, Fasenra is injected every 4 weeks for the first 3 doses, and every 8 weeks afterwards. For the treatment of EGPA and HES, Fasenra is injected every 4 weeks.
If agreed with the treating doctor, patients already using Fasenra and with no history of severe allergic reactions, or their carers, can inject Fasenra themselves after proper training, including on how to watch out for signs and symptoms of allergic reactions. Fasenra should be given for as long as the patient benefits from it, and doctors should re-assess at least once a year whether treatment should be continued.
For more information about using Fasenra, see the package leaflet or contact your doctor or pharmacist.
In eosinophilic asthma, EGPA and HES, symptoms are associated with having too many of a type of white blood cell called eosinophils in the blood and in phlegm in the lungs. The active substance in Fasenra, benralizumab, is a monoclonal antibody (a type of protein) designed to attach to receptors (targets) called interleukin-5 receptors on the surface of eosinophils. By attaching to interleukin-5 receptors, Fasenra activates the immune system (the body’s natural defences) to kill the eosinophils in the blood and lungs. This helps to reduce inflammation, leading to an improvement of symptoms.
Eosinophilic asthma
Fasenra was shown to reduce the number of exacerbations (flare-ups) of asthma during treatment in 2 main studies involving a total of 2,511 patients with eosinophilic asthma that was not adequately controlled by a combination of high-dose inhaled corticosteroids and long-acting beta-agonists. Among patients with the highest number of blood eosinophils before treatment, the number of severe flare-ups per year was 0.66 in patients treated with Fasenra (given every 4 weeks for the first 3 doses and every 8 weeks afterwards), compared with 1.14 in patients given placebo (a dummy treatment).
A third study involving 220 patients showed that more patients given Fasenra had their condition improved to the extent that they could reduce their dose of corticosteroids by an average of 75% compared with 25% of those given placebo.
Eosinophilic granulomatosis with polyangiitis
Fasenra was studied in 140 patients with EGPA that came back or did not respond to previous treatments, who received either Fasenra or mepolizumab (another medicine for EGPA) for one year. The study showed that 57% (40 out of 70) of patients treated with Fasenra achieved remission (no signs and symptoms of vasculitis) at both week 36 and week 48 of treatment; the same proportion of patients who received the comparator also achieved remission at week 36 and 48.
Hypereosinophilic syndrome
A study involving 134 adults and adolescents from 12 years of age with HES showed that treatment with Fasenra delayed the time to the first flare-up and led to fewer flare-ups of the condition compared with placebo. Patients received either Fasenra or placebo every 4 weeks for 24 weeks, in addition to standard HES treatment.
Treatment with Fasenra resulted in a 65% reduction in the risk of flare-ups, compared with placebo: around 22% (15 out of 67) of patients given Fasenra had a flare-up, compared with around 46% (30 out of 66) of patients on placebo.
For the full list of side effects and restrictions of Fasenra, see the package leaflet.
In the treatment of eosinophilic asthma, the most common side effects with Fasenra (which may affect up to 1 in 10 people) include headache and pharyngitis (sore throat). In the treatment of EGPA and HES, the most common side effect is headache.
Fasenra has been shown to be more effective than placebo at reducing the number of asthma flare-ups and the need for corticosteroid treatment. Fasenra was also shown to be as effective as the comparator in the treatment of EPGA, and to reduce the risk of flare-ups in patients with HES.
The medicine is well tolerated with few side effects. The European Medicines Agency therefore decided that Fasenra’s benefits are greater than its risks and recommended that it be approved for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fasenra have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Fasenra are continuously monitored. Side effects reported with Fasenra are carefully evaluated and any necessary action taken to protect patients.
Fasenra received a marketing authorisation valid throughout the EU on 8 January 2018.
Product information
Latest procedure affecting product information:VR/0000288520
03/07/2026
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Fasenra
- Active substance
- Benralizumab
- International non-proprietary name (INN) or common name
- benralizumab
- Therapeutic area (MeSH)
- Asthma
- Anatomical therapeutic chemical (ATC) code
- R03DX10
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic indication
Asthma
Fasenra 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.
News on Fasenra
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