The Therapeutic Goods Administration (TGA) has granted provisional approval to AstraZeneca Pty Ltd to extend the use of its tixagevimab and cilgavimab (EVUSHELD) for the treatment of people with COVID-19.
Provisionally approved uses now include:
- the treatment of mild to moderate COVID-19 in adults:
- who do not require supplemental oxygen; and
- who are at increased risk of progressing to severe COVID-19
- the increase in dose from 300 mg EVUSHELD (150 mg tixagevimab and 150 mg of cilgavimab) to 600 mg EVUSHELD (300 mg of tixagevimab and 300 mg of cilgavimab) for pre-exposure prophylaxis (prevention) of COVID-19 in people aged 12 years and older weighing at least 40 kg:
- who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination; or
- for whom vaccination is not recommended due to a history of severe adverse reaction to a COVID‐19 vaccine or COVID‐19 vaccine component(s).
EVUSHELD received initial provisional approval on 24 February 2022 for the pre-exposure of prophylaxis of COVID-19. Pre-exposure prevention with EVUSHELD is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.
In making this regulatory decision, the TGA carefully considered data from the following trials:
- The PROVENT trial Substudy (study D8850C002A01), a Phase III randomised, double-blind, placebo-controlled trial in adults for the pre-exposure prevention of COVID-19. This study demonstrated that EVUSHELD significantly reduced the risk of symptomatic COVID-19 illness or death compared to the placebo.
- The TACKLE trial (study D8550C00003), a Phase III randomised, double blind, placebo-controlled, multicentre study in adults for the treatment of COVID-19. This study demonstrated EVUSHELD used as a treatment reduced the risk of developing severe COVID-19 or death by 50%, and also reduced the risk of hospitalisation.
Provisional approval of EVUSHELD is subject to certain strict conditions, such as the requirement for the sponsors to continue providing information to the TGA on longer-term efficacy and safety from ongoing clinical trials and post-market assessment. The decision was informed by expert advice from the Advisory Committee on Medicines, an independent committee with expertise in scientific, medical and clinical fields as well as consumer representation.
Supporting regulatory documents
The provisional approval pathway provides a formal and transparent mechanism for registration of promising new medicines with preliminary clinical data.
The following regulatory documents are made available as part of this process:
- Product information (PI)
- Consumer Medicine Information (CMI)
- EVUSHELD Decision Summary
The decision summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the ARTG.
- AusPAR: Tixagevimab and cilgavimab (EVUSHELD) - initial provisional registration, for the use in individuals aged 12 years or older weighing at least 40 kg for pre-exposure prevention (prophylaxis) of COVID-19
An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission.
- AusPAR: Tixagevimab and cilgavimab (EVUSHELD) - extension of indications for the use in individuals aged 12 years or older weighing at least 40 kg for treatment of COVID-19 and the increase to dose for pre-exposure prevention (prophylaxis) of COVID-19
- Therapeutic Goods (Poisons Standard) (COVID-19 Medicine - AstraZeneca) (Tixagevimab and Cilgavimab) Labelling Exemption 2022