Remdesivir (5) – Veklury®

COVID-19, no need for supplemental oxygen, ≥ 4 weeks, ≥ 3 kg to <40 kg

Characteristics

Start date 15.07.2025 – Marketing authorisation: 06.06.2025
Resolution 22.01.2026
INN Remdesivir
Brand name Veklury®
Pharm. company Gilead Sciences GmbH
G-BA Procedure ID D-1221
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
Therapeutic area Infectious diseases
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

Veklury is used to treat coronavirus disease 2019 (COVID-19) in children and adolescents aged at least 4 weeks and weighing ≥ 3 to < 40 kg, who do not require supplemental oxygen and are at increased risk of developing severe COVID-19.
Subpopulation Indication Comparator
Kinder und Jugendliche im Alter von mindestens 4 Wochen mit einem Körpergewicht von ≥ 3 bis < 40 kg mit einer COVID-19-Erkrankung, die keine zusätzliche Sauerstoffzufuhr benötigen und ein erhöhtes Risiko haben, einen schweren COVID-19-Verlauf zu entwickeln

Studies and Results

Children and adolescents aged at least 4 weeks with a body weight of ≥ 3 to < 40 kg who have COVID-19, do not require supplemental oxygen and are at increased risk of developing a severe course of COVID-19

  • The additional benefit is not proven.
  • In its dossier, the pharmaceutical manufacturer does not provide any data for the assessment of the additional benefit of remdesivir compared with the appropriate comparator therapy.
  • There are therefore no data available to assess the additional benefit of remdesivir for the treatment of coronavirus disease 2019 (COVID-19) in children and adolescents aged at least 4 weeks and weighing ≥ 3 to < 40 kg who do not require supplemental oxygen and are at increased risk of developing severe COVID-19.
  • The pharmaceutical manufacturer has not submitted any data to demonstrate the additional benefit of remdesivir compared with the appropriate comparator therapy.
  • Consequently, no additional benefit of remdesivir has been demonstrated for the treatment of children and adolescents aged at least 4 weeks and weighing ≥ 3 to < 40 kg with COVID-19, who do not require supplemental oxygen and are at increased risk of developing severe COVID-19, there is no proof.
  • Appropriate comparator therapy
    • The appropriate comparator therapy was defined as follows: Children and adolescents aged at least 4 weeks with a body weight of ≥ 3 to < 40 kg who have COVID-19, do not require supplemental oxygen and are at increased risk of developing severe COVID-19
    • Appropriate comparator therapy for remdesivir: - best supportive care
    • Taking all factors into account, the G-BA therefore designates best supportive care as the appropriate comparator therapy for remdesivir in the therapeutic situation under assessment.
    • ‘Best supportive care’ is understood to mean the treatment that ensures the best possible, individually optimised supportive care for the patient, aimed at alleviating symptoms and improving quality of life.

Courtesy translation only, please refer to the German original.

Associated procedures



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