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The European Commission (EC) has provided conditional marketing authorisation for Gilead Sciences to use Veklury (remdesivir) for the treatment of Covid-19.
Gilead noted that the approval comes after a rolling review of supporting data that started in April.
The authorisation enables the use of Veklury in adults and adolescents aged 12 years and above with Covid-19-related pneumonia who need supplemental oxygen.
Gilead Sciences chief medical officer Merdad Parsey said: “We appreciate the European Medicines Agency’s rapid review of remdesivir in recognition of the unprecedented nature of this pandemic.
“This conditional marketing authorisation is an important step forward as we work together to address the treatment needs of patients across Europe.”
Veklury is a nucleotide analogue said to possess broad-spectrum antiviral activity in-vitro, as well as in-vivo in animal models against various emerging viral pathogens.
The drug is currently in multiple international Phase III clinical trials assessing its safety and efficacy, including in combination with anti-inflammatory medicines and in special populations such as paediatric patients.
In addition, research is underway to investigate new, investigational formulations of remdesivir that may enable studies in earlier stages of the viral disease.
So far, Veklury has been studied in hospitalised Covid-19 patients across a range of disease severity.
The conditional marketing authorisation in Europe is supported by data from the US National Institute of Allergy and Infectious Diseases’ global Phase III trial of remdesivir.
Initially, the conditional approval is valid for one year but can be extended or converted into an unconditional marketing authorisation following the submission and review of additional confirmatory data.
In May, Gilead received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for remdesivir to treat Covid-19.
Furthermore, the drug is approved as a Covid-19 treatment in Japan, Taiwan, India, Singapore and the UAE.
Last month, Gilead said that the price of a five-day treatment course of the remdesivir is set at $2,340 per patient, or $390 per vial, for the US and governments of other developed countries.