Gilead Sciences has secured conditional marketing authorisation from the European Commission for its Veklury (remdesivir) to treat SARS-CoV-2 infection, which is responsible for the Covid-19 disease.
As part of the conditional marketing authorisation, Veklury will be used to treat Covid-19 disease in adults and adolescents, aged 12 years and older and weighing at least 40kg, with pneumonia requiring supplemental oxygen.
Veklury is a nucleotide analogue with a wide antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens.
Gilead has assessed Veklury in hospitalised Covid-19 patients spanning a range of disease severity.
The conditional marketing authorisation is based on the data of the US National Institute of Allergy and Infectious Diseases’ global phase 3 trial of remdesivir.
Gilead stated that the European conditional marketing authorisation is initially valid for one year, and can be extended or converted into an unconditional marketing authorisation after the submission and evaluation of additional confirmatory data.
In addition, ongoing clinical trials continue to assess the safety and efficacy of remdesivir, including studies of remdesivir in combination with anti-inflammatory medicines and in special populations including pediatric patients.
The company will also carry out research on new and investigational formulations of remdesivir, which may enable studies of the drug in earlier stages of the disease.
Various ongoing international phase 3 clinical trials are assessing the safety and efficacy of remdesivir to treat Covid-19 disease.
In the US, the remdesivir (GS-5734) secured emergency use authorisation (EUA) in the US to treat patients with suspected or laboratory-confirmed SARS-CoV-2 infection and severe Covid-19.
The remdesivir has also secured approval to treat patients with severe Covid-19 in Japan, Taiwan, India, Singapore, and UAE, in addition to the European Union.
Gilead Sciences chief medical officer Dr 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 authorization is an important step forward as we work together to address the treatment needs of patients across Europe.”
In June, Gilead Sciences agreed to acquire 49.9% equity stake in Pionyr Immunotherapeutics for $275m.