SINGAPORE (THE BUSINESS TIMES) – Singapore has inked a deal with drugmaker GlaxoSmithKline Singapore and clinical-stage immunology firm Vir Biotechnology for the supply of a medication for patients with mild to moderate Covid-19.
The advance purchase agreement is for the supply of sotrovimab, an investigational single-dose monoclonal antibody administered through intravenous infusion, GSK Singapore said in a statement on Wednesday (June 29).
It is used to treat Covid-19 patients who do not need supplemental oxygen but are at risk of progressing to severe disease.
Sotrovimab is currently undergoing regulatory review by the Health Sciences Authority for interim authorisation under the Pandemic Special Access Route (PSAR), GSK Singapore said.
The medication was, on May 26, granted emergency-use authorisation by the United States Food and Drug Administration; the European Medicines Agency’s Committee for Medicinal Products for Human Use has also issued a positive scientific opinion.
The British drugmaker’s PSAR application includes data from an interim analysis of efficacy and safety data from its phase three trial, which it said was stopped early by an independent data-monitoring committee in March due to evidence of “profound clinical efficacy”.
“Results of the interim analysis, based on data from 583 randomised patients, demonstrated an 85 per cent reduction in hospitalisation or death in those receiving sotrovimab compared to placebo, the primary endpoint of the trial,” GSK Singapore said.
It noted that the PSAR review will also consider the medicine’s quality and safety data, adding that final results from its efficacy trial will be available later this year.
Preclinical data has suggested that sotromivab targets a conserved epitope of the Sars-CoV-2 spike protein, which is less likely to mutate over time, GSK said.
Dr Phil Pang, chief medical officer of Vir, said the treatment appears to “retain activity against all circulating variants of concern”, including the highly transmissible Delta variant which originated from India, based on data from several in vitro studies.
Mr Mike Crichton, senior vice-president for speciality and primary-care therapy area at GSK, said vaccines, together with treatments like sotrovimab, have the potential to increase the chance of ending the pandemic, as variants of the coronavirus continue to arise.
GSK and Vir are in discussions with other governments to explore similar supply agreements, as countries accelerate their vaccine and therapeutics programmes against Covid-19, the company said.