Conditional approval for Gilead’s remdesivir in Europe

The European Commission has granted conditional marketing authorisation for Gilead’s Veklury (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19.

The authorisation was granted in the interest of public health due to the COVID-19 pandemic and was based on a rolling review of supporting data that began in April 2020.

Under this authorization, Veklury is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg), with pneumonia requiring supplemental oxygen.

“We appreciate the European Medicines Agency’s rapid review of remdesivir in recognition of the unprecedented nature of this pandemic,” said Merdad Parsey, Chief Medical Officer, Gilead Sciences.

“This conditional marketing authorization is an important step forward as we work together to address the treatment needs of patients across Europe.”

Veklury has been studied in hospitalized COVID-19 patients spanning a range of disease severity.

The conditional marketing authorization for Veklury is supported by the US National Institute of Allergy and Infectious Diseases’ global Phase 3 trial of remdesivir. A conditional marketing authorisation in Europe is initially valid for one year but can be extended or converted into an unconditional marketing authorization after the submission and assessment of additional confirmatory data.

Ongoing clinical trials continue to evaluate the safety and efficacy of remdesivir, including studies of remdesivir in combination with anti-inflammatory medicines and in special populations including paediatric patients.

Research is also being conducted on new, investigational formulations of remdesivir that may enable studies of remdesivir in earlier stages of disease.

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