COVID-19 treatment: Gilead Sciences Pty Ltd, remdesivir (VEKLURY)

The Therapeutic Goods Administration (TGA) has granted provisional approval to Gilead Sciences Pty Ltd to extend the use of the COVID-19 treatment, VEKLURY (remdesivir). Provisionally approved uses now include:

• adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) who have pneumonia due to SARS-CoV-2, who require supplemental oxygen, and
• adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.

The decision follows the provisional approval granted by the TGA to Gilead Sciences Pty Ltd on 10 July 2020 for the use of VEKLURY in adults and adolescents aged 12 years and older (and weighing at least 40 kg) with pneumonia who have been hospitalised and require oxygen. This was the first treatment option for COVID-19 to be provisionally approved by the TGA.

In making this regulatory decision, the TGA carefully considered data from the following trials:

• The CARAVAN study (study GS-US-540-5823), a Phase II/III open arm study in children under 18 years of age, which demonstrated clinical improvement and recovery in a high proportion of hospitalised patients, and
• The PINETREE trial (study GS-US-540-9012), a Phase III study in participants aged 12 years and older (weighing over 40 kg), which demonstrated that VEKLURY significantly reduced the risk of hospitalisation or death.

Provisional approval of VEKLURY is subject to certain strict conditions, such as the requirement for the sponsor 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.

VEKLURY has also received approval from the United States Food and Drug Administration (US FDA) for these extended indications (uses). The European Medicines Agency (EMA) has approved the extension of indication for adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19, and an application to extend the use of VEKLURY to include children is currently under evaluation. Health Canada is also currently evaluating an application to extend the use of VEKLURY in adults but has not yet received an application to extend the use in children.

Provisional approval of this treatment option is valid for two years. The sponsor, Gilead Sciences Pty Ltd, may apply for full registration when additional clinical data required by the TGA to confirm the safety and efficacy of the medicine are available.

Supporting regulatory documents

The provisional approval pathway provides a formal and transparent mechanism for speeding up the registration of promising new medicines with preliminary clinical data.

The following regulatory documents are made available as part of this process:

• VEKLURY (remdesivir) Product Information (PI)
• VEKLURY (remdesivir) Consumer Medicine Information (CMI)
• 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: Remdesivir – initial provisional registration, for use in individuals aged 12 years and older with severe COVID-19 symptoms who have been hospitalised.
  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: Remdesivir – Extension of indication, for use in adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia due to SARS-CoV-2, who require supplemental oxygen; and for use in adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
• Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2021 (repealed)
• Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2022