In Phase 3 COMET-ICE trial, sotrovimab reduced 85% risk of hospitalisation or death in high-risk adult patients compared to placebo
FDA authorises GSK-Vir’s Covid-19 drug sotrovimab. (Credit: PIRO4D from Pixabay.)
GlaxoSmithKline (GSK) and Vir Biotechnology have received an Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its sotrovimab to treat mild-to-moderate Covid-19.
Previously called VIR-7831, the drug is authorised to treat mild-to-moderate Covid-19 in adults and paediatric patients aged 12 years and above, who are at high risk for Covid-19 hospitalisation or death.
Sotrovimab is an investigational SARS-CoV-2 monoclonal antibody therapy that targets a conserved epitope of the spike protein which has fewer chances for mutation over time.
It leverages Xtend technology from Xencor and is designed to achieve high concentration in the lungs to facilitate optimal penetration into airway tissues affected by SARS-CoV-2.
GSK chief scientific officer and R&D president Hal Barron said: “The fast pace of Covid-19 vaccinations in the U.S. is encouraging, yet, despite these aggressive efforts, there is still a need to help prevent infected patients from developing complications.
“In just over a year since starting our collaboration and in less than 10 months since beginning clinical trials, we are delighted that, as of today, the benefits of this unique monoclonal antibody will now be available to patients in need.”
The US FDA authorised sotrovimab based on an interim analysis from COMET-ICE, a Phase 3 randomised, double-blind, placebo-controlled clinical trial in 583 non-hospitalised Covid-19 patients.
The EUA submission included data from studies, which showed that sotrovimab is active against variants from Brazil (P.1), California (B.1.427/B.1.429), India (B.1.617), New York (B.1.526), South Africa (B.1.351) and the UK (B.1.1.7).
The interim study results showed that sotrovimab reduced 85% risk of hospitalisation or death for more than 24 hours compared to placebo, which is the primary endpoint of the trial.
COMET-ICE trial investigator Adrienne E Shapiro said: “Monoclonal antibodies like sotrovimab are potentially one of our most effective tools for fighting Covid-19.
“While preventive measures, including vaccines, can reduce the total number of cases, sotrovimab is an important treatment option for those who become ill with Covid-19 and are at high risk – allowing them to avoid hospitalisation or worse.”
The safety and effectiveness of sotrovimab in treating Covid-19 is continued to be evaluated and the drug is not authorised for hospitalised Covid-19 patients who require oxygen therapy.
Furthermore, the EUA includes a warning for hypersensitivity, including anaphylaxis and infusion-related reactions.