Tezspire (tezepelumab)
- Region
- 🇪🇺 EU
- Active substance
- tezepelumab
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- Asthma; Sinusitis
- CHMP opinion
- Thu 21 Jul 2022
- EU approval
- Mon 19 Sep 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005588
- ATC
- R03DX11
- Official record
- www.ema.europa.eu
Indication
AsthmaTezspire 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. Chronic rhinosinusitis with nasal polyps (CRSwNP) Tezspire is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids, and/or surgery do not provide adequate disease control.
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.