The UAE’s health ministry, on Saturday, approved the emergency use of a highly effective new treatment for Covid-19.
The Ministry of Health and Prevention (MoHAP) approved the emergency use of Sotrovimab (Vir-7831), becoming the first country in the world to both licence and enable immediate patient use. The drug was recently endorsed by the US Food and Drug Administration.
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Sotrovimab is an investigational single-dose monoclonal antibody, for the treatment of mild-to-moderate Covid-19 in adults and paediatric patients, 12 years of age and older weighing at least 40 kg. The drug has been developed by GlaxoSmithKline (GSK) and Vir Biotechnology.
Clinical trials stated that the drug shows positive results of direct Sars-CoV-2 viral testing, and is an effective treatment for those who are at high risk for progression to severe Covid, including hospitalisation or death.
Mohap said the treatment offered the prospect of reducing hospitalisation for more than 24 hours and fatalities by as much as 85 per cent when administered to patients as an early treatment against the coronavirus.
Furthermore, in pre-clinical studies, Sotrovimab has demonstrated effectiveness as a monotherapy against widely circulating variants of the disease, including the one from India, according to George Scangos, chief executive officer of Vir.
AbdulRahman bin Mohamad Al Owais, Minister of Health and Prevention, said, “The new medicine will greatly contribute to speeding up the recovery of patients, reducing Covid-19-related deaths and hospitalization period in intensive care units.”
He added. “It will also support the country’s efforts being made to conduct Covid-19 tests and administer vaccines.”
The Ministry has already put in place protocols to ensure early access and has devised guidelines for doctors for appropriate use of the medicine.
Dr Mohamed Salim Al Olama, Under-Secretary at Mohap, said, “We have been pleased to partner with GSK to ensure that critical elements are in place to ensure early access, from licensing and shipments to training and new guidelines for doctors.” New guidelines are also in place to guide doctors on appropriate use and how to direct patients to the centres where sotrovimab will be available.
"We are working in close partnership with the MOHAP to ensure that our innovative medicines and vaccines are available to the patients who need them," said Gizern Akalin, Managing Director and Vice President, GSK Gulf, based in Dubai.
Evidence of Sotrovimab’s clinical efficacy
The FDA granted emergency use authorisation to Sotrovimab based on an interim analysis of efficacy and safety data from the Phase 3 Covid-19 Monoclonal antibody Efficacy Trial – Intent to Care Early (COMET-ICE) trial in high-risk adult outpatients.
The interim study results demonstrated an 85 per cent reduction in hospitalisation for more than 24 hours or death in those receiving sotrovimab compared to placebo, the primary endpoint of the trial.
The most common adverse events observed in the sotrovimab treatment group in COMET-ICE were rashes at 2 per cent and diarrhoea at one per cent, all of which were graded at mild or moderate.
Adrienne E. Shapiro, M.D., Ph.D., an infectious disease specialist at Fred Hutchinson Cancer Research Center and investigator in the COMET-ICE trial, said, “Monoclonal antibodies like sotrovimab are potentially one of our most effective tools for fighting the coronavirus. 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.”
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