Basic Information
R03DX11
tezepelumab
Drugs for obstructive airway diseases
Therapeutic indication
Tezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
Overview Summary
Tezspire is a medicine used to treat adults and adolescents (12 years of age and older) with severe asthma. It is used as an additional treatment in adults and adolescents with severe asthma that is not adequately controlled by a combination of high-dose corticosteroids taken by inhalation plus another asthma medicine.
Tezspire contains the active substance tezepelumab.
Active Substances (2)
tezepelumab
tezepelumab
Documents (10)
Tezspire : EPAR - Risk-management-plan
September 21, 2022
RISK_MANAGEMENT_PLAN_SUMMARY
Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
September 22, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Tezspire : EPAR - Public assessment report
September 21, 2022
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Tezspire-H-C-005588-P46-008 : EPAR - Assessment report
August 10, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Tezspire-H-C-5588-P46-007 : EPAR - Assessment report
June 5, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Tezspire : EPAR - Public assessment report
September 21, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Tezspire : EPAR - Medicine overview
September 21, 2022
OVERVIEW_DOCUMENT
Tezspire : EPAR - Product Information
September 21, 2022
DRUG_PRODUCT_INFORMATION
Tezspire : EPAR - Procedural steps taken and scientific information after authorisation
November 8, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Tezspire : EPAR - All Authorised presentations
September 21, 2022
AUTHORISED_PRESENTATIONS
Overview Q&A (7)
Question
How is Tezspire used?
Answer
Tezspire can only be obtained with a prescription and treatment should be initiated by a doctor with experience in diagnosing and treating severe asthma.
Tezspire is injected under the skin every 4 weeks. This medicine is used for long-term treatment. Every year the doctor will decide whether to continue treatment, based on the patient’s level of asthma control.
The patient or their caregiver may inject the medicine themselves after they have received training.
Tezspire should not be used to treat asthma attacks. Patients should contact their doctor if their asthma remains uncontrolled or worsens after starting this medicine.
For more information about using Tezspire, see the package leaflet or contact your doctor or pharmacist.
Question
How does Tezspire work?
Answer
In patients with asthma, a protein called thymic stromal lymphopoietin (TSLP) plays a role in the immune response that causes inflammation in the airway. The active substance of Tezspire, tezepelumab, is an antibody (a type of protein) that prevents TSLP from attaching to its receptor and thereby reduces airway inflammation and asthma symptoms.
Question
What benefits of Tezspire have been shown in studies?
Answer
Two main studies including over 1,500 adults and adolescents with inadequately controlled asthma showed that Tezspire was effective in reducing the number of severe asthma flare?ups.
In the first study, patients given Tezspire had on average 0.93 asthma flare?ups per year after one year of treatment compared with 2.10 in patients given placebo (a dummy treatment). In the second study, patients taking Tezspire had an average of 0.20 flare?ups per year after one year, compared with 0.72 in patients who received placebo.
Question
What are the risks associated with Tezspire?
Answer
The most common side effects with Tezspire (which may affect up to 1 in 10 people) are arthralgia (joint pain) and pharyngitis (sore throat).
For the full list of side effects and restrictions of Tezspire, see the package leaflet.
Question
Why is Tezspire authorised in the EU?
Answer
The European Medicines Agency decided that Tezspire’s benefits are greater than its risks and it can be authorised for use in the EU.
The Agency considered that Tezspire was effective at reducing severe asthma flare?ups. Regarding safety, side effects related to Tezspire were considered manageable.
Question
What measures are being taken to ensure the safe and effective use of Tezspire?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tezspire have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Tezspire are continuously monitored. Suspected side effects reported with Tezspire are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Tezspire
Answer
Tezspire received a marketing authorisation valid throughout the EU on 19 September 2022.
This overview was last updated in 09-2022.