Remdesivir (4) – Veklury®

COVID-19, no requirement for supplementary oxygen, < 18 years, ≥ 40 kg)

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-887
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 (with a body weight of at least 40 kg) who do not require supplemental oxygen and are at increased risk of developing a severe COVID-19 course.
Subpopulation Indication Comparator
Children and adolescents with a minimum body weight of 40 kg with COVID-19 disease who do not require supplemental oxygen and are at increased risk of developing a severe COVID-19 course Treatment according to physican's choice

Studies and Results

No. of studies
(best subpopulation) 		1 (Studie GS5823) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: Single-arm + no comparison)

  • Clinical trials
    • The GS9012 trial is a placebo-controlled, double-blind, randomised Phase 3 trial investigating outpatient treatment with remdesivir in patients in the early stages of COVID-19.

Children and adolescents with a minimum body weight of 40 kg who have COVID-19, do not require supplemental oxygen and are at increased risk of developing severe COVID-19

  • Additional benefit is not proven for the treatment of children and adolescents with a minimum body weight of 40 kg who have COVID-19, do not require supplemental oxygen and are at increased risk of developing severe COVID-19.
  • Overall, for children and adolescents with a minimum body weight of 40 kg who have COVID-19, do not require supplemental oxygen and are at increased risk of developing severe COVID-19, the additional benefit of remdesivir compared with the appropriate comparator therapy is not proven.
  • mortality
    • Of the 584 patients included, only 8 belonged to the patient population under consideration here (N = 3 in the intervention arm and N = 5 in the control arm). Among these 8 patients, aged 12 to < 18 years and weighing at least 40 kg, no events occurred with regard to the endpoints assessed.
  • morbidity
    • Of the 584 patients included, only 8 belonged to the patient population under consideration here (N = 3 in the intervention arm and N = 5 in the control arm). Among these 8 patients aged 12 to < 18 years and weighing at least 40 kg, no events occurred with regard to the endpoints assessed.
  • Health-related quality of life
    • Of the 584 patients included, only 8 belonged to the patient population under consideration here (N = 3 in the intervention arm and N = 5 in the control arm). Among these 8 patients aged 12 to < 18 years and weighing at least 40 kg, no events occurred with regard to the endpoints assessed.
  • Side effects
    • Among these 8 patients aged 12 to < 18 years and weighing at least 40 kg, no events occurred at the endpoints assessed – with the exception of a single adverse event (AE) in the control arm (Preferred Term: fatigue) – no events occurred.

Courtesy translation only, please refer to the German original.

Associated procedures



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