Veklury label extension

On 16 December 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Veklury. The marketing authorisation holder for this medicinal product is Gilead Sciences Ireland UC.

The CHMP adopted a change to the existing indication as follows:¹

Veklury is indicated for the treatment of coronavirus disease 2019 (COVID‑19) in:

• adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
• adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).