Veklury EU approval : Gilead Sciences said that Veklury (remdesivir) has been given conditional marketing authorization from the European Commission as a treatment for SARS-CoV-2 infection, the virus behind COVID-19.
According to the US pharma company, the conditional marketing authorization for Veklury was given in the interest of public health because of the coronavirus pandemic and was based on a rolling review of supporting data that commenced in April 2020.
Veklury has been indicated for COVID-19 treatment in adults and adolescents who are having pneumonia and need supplemental oxygen.
Commenting on Veklury EU approval, Merdad Parsey – Chief Medical Officer of Gilead Sciences said: “We appreciate the European Medicines Agency’s rapid review of remdesivir in recognition of the unprecedented nature of this pandemic.
“This conditional marketing authorization is an important step forward as we work together to address the treatment needs of patients across Europe.”
Gilead Sciences said that Veklury has been assessed in hospitalized COVID-19 patients having a range of disease severity. The conditional marketing authorization for Veklury is backed by the US National Institute of Allergy and Infectious Diseases’ global phase 3 trial of remdesivir.
The conditional marketing authorization of the coronavirus drug in Europe is valid initially for a year but can be extended or converted into an unconditional marketing authorization following the submission and evaluation of additional confirmatory data.
Gilead Sciences said that clinical trials continue to go on for assessing the safety and efficacy of remdesivir, including studies of the nucleotide analog in combination with anti-inflammatory medicines and in special populations that include pediatric patients.
Research is also being held on new, investigational formulations of remdesivir that could facilitate studies of the nucleotide analog in earlier stages of the disease.