MedPath
EMA Approval

Tezspire

R03DX11

tezepelumab

Drugs for obstructive airway diseases

tezepelumab

Asthma

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.

Authorisations (1)

EMEA/H/C/005588

AstraZeneca AB,151 85 Sodertalje,Sweden

Authorised

September 19, 2022

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.

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