The conditional marketing authorisation was granted based on the US National Institute of Allergy and Infectious Diseases’ global Phase 3 trial of remdesivir
EC grants conditional marketing authorisation for Veklury (remdesivir) to treat Covid-19. (Credit: Visuals3D from Pixabay.)
US-based biopharmaceutical company Gilead Sciences has secured the European Commission conditional marketing authorisation for Veklury (remdesivir) to treat SARS-CoV-2 infection.
The company said that the conditional marketing authorisation was granted during the Covid-19 pandemic, based on a rolling review of supporting data that began in April 2020.
The EC authorisation indicated Veklury 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.
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.”
Several clinical trials have been evaluating Veklury in hospitalised Covid-19 patients
Veklury is a nucleotide analogue with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens.
Various international Phase 3 clinical trials have been evaluating the safety and efficacy of remdesivir for the treatment of SARS-CoV-2, the virus that causes Covid-19, in hospitalised patients.
Also, the current public health emergency and available clinical data enabled the approval of remdesivir for patients with severe Covid-19 in Japan, Taiwan, India, Singapore, the UAE and the EU.
The conditional marketing authorisation was granted based on the global Phase 3 trial of remdesivir, conducted by the US National Institute of Allergy and Infectious Diseases.
The company said that the European conditional marketing authorisation is primarily valid for one year, and can be extended or converted into a full marketing authorisation through submission and assessment of additional confirmatory data.
The current clinical trials evaluate the safety and efficacy of remdesivir, including in combination with anti-inflammatory medicines and in special populations including paediatric patients.
Furthermore, ongoing research conducted on new, investigational formulations of remdesivir is expected to enable studies of remdesivir in earlier stages of the disease.