Fasenra | European Medicines Agency (EMA)

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Overview

Fasenra is an asthma medicine used to treat adults with 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. 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 severe asthma.

The recommended dose is 30 mg injected under the skin of the thighs or belly every 4 weeks for the first 3 doses, and every 8 weeks afterwards. If the injection is given by a doctor or carer, it can also be given under the skin of the upper arm. 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, 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, resulting in a reduction in asthma attacks and improvement of symptoms.

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.

The most common side effects with Fasenra (which may affect up to 1 in 10 people) include headache and pharyngitis (sore throat). For the full list of side effects and restrictions of Fasenra, see the package leaflet.

Fasenra has been shown to be more effective than placebo at reducing the number of asthma flare-ups and the need for corticosteroid treatment. 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.

English (EN)
(68.26 KB – PDF)

First published: 08/03/2018Last updated: 27/08/2019

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English (EN)
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First published: 14/02/2025

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Product information

English (EN)
(1.36 MB – PDF)

First published: 08/03/2018Last updated: 14/02/2025

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Latest procedure affecting product information:
II/0052

24/10/2024

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).

English (EN)
(22.99 KB – PDF)

First published: 08/03/2018Last updated: 27/08/2019

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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 diseases

Therapeutic 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 (see section 5.1).

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