🇺🇸 Tezspire in United States

FDA authorised Tezspire on 17 December 2021 · 3,389 US adverse-event reports

Marketing authorisations

FDA — authorised 17 December 2021

  • Application: BLA761224
  • Marketing authorisation holder: ASTRAZENECA AB
  • Local brand name: Tezspire
  • Status: supplemented

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Asthma — 795 reports (23.46%)
  2. Dyspnoea — 478 reports (14.1%)
  3. Drug Ineffective — 437 reports (12.89%)
  4. Arthralgia — 434 reports (12.81%)
  5. Cough — 239 reports (7.05%)
  6. Pneumonia — 219 reports (6.46%)
  7. Headache — 199 reports (5.87%)
  8. Back Pain — 198 reports (5.84%)
  9. Rash — 198 reports (5.84%)
  10. Fatigue — 192 reports (5.67%)

Source database →

Tezspire in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Tezspire approved in United States?

Yes. FDA authorised it on 17 December 2021; FDA has authorised it.

Who is the marketing authorisation holder for Tezspire in United States?

ASTRAZENECA AB holds the US marketing authorisation.