Remdesivir (3) – Veklury®

COVID-19, need for supplementary oxygen, ≥ 4 weeks - < 12 years

Characteristics

Start date 15.10.2022 – Marketing authorisation: 16.09.2022
Resolution 06.04.2023
INN Remdesivir
Brand name Veklury®
Pharm. company Gilead Sciences GmbH
G-BA Procedure ID D-879
ATC code J05AB16 Nucleosides and nucleotides excl. reverse transcriptase inhibitors (J05AB)
ICD-10 codes (AIS) J06.9Upper respiratory disease, acute
Alpha-ID codes (AIS) I4988Acute infection of the upper respiratory tract
DDD 0.1 g P
Therapeutic area Infectious diseases COVID-19
Reason for procedure New therapeutic indication
Specialty Bundling

Therapeutic indication of the resolution

Veklury is used to treat 2019 coronavirus disease (COVID-19) in pediatric patients (aged at least 4 weeks to 11 years and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen therapy or other non-invasive ventilation at therapy initiation).
Subpopulation Indication Comparator
Children aged 4 weeks to 11 years and with a minimum body weight of 3 kg with COVID-19 disease and pneumonia requiring supplementary oxygenation Therapy according to physician's choice

Studies and Results

No. of studies
(best subpopulation) 		0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: H2H vs. non-ACT + no ITC)

  • Clinical trials
    • The GS5823 trial was an open-label, single-arm study that included patients aged 0 days to < 18 years with confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.

Children aged 4 weeks to 11 years with a minimum body weight of 3 kg who have COVID-19 and pneumonia requiring supplemental oxygen

  • An additional benefit is not proven for the treatment of children aged 4 weeks to 11 years and with a minimum body weight of 3 kg who have COVID-19 and pneumonia requiring supplemental oxygen.
  • No relevant RCT was identified for the assessment of additional benefit in which remdesivir was compared with the appropriate comparator therapy.
  • To assess the additional benefit of remdesivir in this indication, the pharmaceutical manufacturer has submitted study GS5823.
  • Of these, at least 33 patients do not meet the criteria for the therapeutic indication under assessment due to their age and/or ventilator status.
  • For the assessment of the additional benefit of remdesivir in the treatment of children aged between 4 weeks and 11 years with a minimum body weight of 3 kg who have COVID-19 and pneumonia, requiring supplemental oxygen, the pharmaceutical manufacturer has therefore not submitted any suitable data in comparison with the appropriate comparator therapy.
  • Nor is sufficient justification provided for the extrapolation of the results of the meta-analytical synthesis of the ACTT-1, GS5774-A and CAP-2 studies—conducted in adults—to children aged 4 weeks to 11 years with a minimum body weight of 3 kg.
  • Overall, for children aged between 4 weeks and 11 years with a minimum body weight of 3 kg who have COVID-19 and pneumonia requiring supplemental oxygen, the additional benefit of remdesivir compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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