SINGAPORE: The Health Sciences Authority (HSA) has granted interim authorisation for an antibody drug known as sotrovimab to be used in the treatment of COVID-19 patients.
Developed by GlaxoSmithKline (GSK) and Vir Biotechnology, sotrovimab can be used to treat patients aged 18 and older with mild to moderate COVID-19 who do not require supplemental oxygen, but are at risk of progression to severe forms of the disease.
“The at-risk factors include being aged 55 years and above, and/or having comorbidities such as chronic kidney disease, chronic obstructive pulmonary disease, congestive heart failure, diabetes, moderate to severe asthma and obesity,” HSA said on Wednesday (Jun 30).
The interim authorisation, given under the Pandemic Special Access Route, comes after HSA reviewed data from an ongoing trial.
“HSA’s review of the available clinical data based on rolling submission of the results from a Phase II/III study found that sotrovimab demonstrated a 79 per cent reduction in the relative risk for progression to requiring acute treatment in hospital or death due to COVID-19 compared to placebo,” the agency said.
“There was also a smaller proportion of subjects who progressed to severe and/or critical respiratory disease requiring oxygen supplementation in the sotrovimab group – 1 per cent – compared to the placebo group – 5 per cent.”
The clinical trial involved more than 1,000 people aged between 18 and 96 who all had risk factors for progression to severe COVID-19.
Sotrovimab is the first drug for treating COVID-19 to be given interim authorisation by HSA under the Pandemic Special Access Route.
The Pfizer-BioNTech and Moderna COVID-19 vaccines were granted interim authorisation under the route earlier.
HSA also granted conditional approval for the use of the drug remdesivir in treating COVID-19 in June 2020.
Sotrovimab was granted emergency use authorisation in the United States on May 26.
The therapy is based on monoclonal antibodies, which are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses, according to the US Food and Drug Administration (FDA).
“Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus’ attachment and entry into human cells,” the FDA said.
It has also been approved for use in Abu Dhabi and Bahrain.
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HSA said that the safety data on sotrovimab showed that it is “well-tolerated” by patients.
“The common adverse events reported in the clinical study were headache, dehydration, nausea and diarrhoea,” it said.
“The incidences of these adverse events were generally low and were reported at similar or lower incidences compared to the placebo group."
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As a requirement of interim authorisation, GSK will collect relevant safety data and monitor the use of sotrovimab.
“HSA will also require GSK to continue submitting updated clinical and pharmacology data from ongoing clinical studies to ensure the continued safety and efficacy of the product,” the agency said.
“As there is currently insufficient clinical data to assess the efficacy of sotrovimab in the presence of circulating SARS‐CoV‐2 variants, GSK will also need to submit relevant data on this for HSA’s continuous benefit‐risk assessment.
“HSA will actively review the data submitted by GSK to ensure that the benefits of sotrovimab continue to outweigh the known risks."
GSK will be required to file an application for full product registration when sufficient data is available, HSA added.
Interim authorisation of vaccines, medicines and medical devices under the Pandemic Special Access Route can be terminated by HSA at any time, such as when new data suggests that their benefits no longer outweigh their risks.