A new monoclonal antibody drug produced by Vir Biotechnology and GlaxoSmithKline has been approved for use in the treatment of mild to moderate COVID-19 adult patients by the US Food and Drug Administration. The makers of the drugs made the announcement on May 26.
The new drug, Sotrovimab, is the third antibody drug that is authorised to treat COVID-19 patients, especially those who are at high risk of developing more severe symptoms. The antibody medicines are usually given early in the course of the viral disease.
"The US Food and Drug Administration issued an emergency use authorisation (EUA) for the investigational monoclonal antibody therapy Sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms ) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalisation or death,” FDA said in a statement on May 26.
The drug showed an efficacy rate of 85 percent in its trials in preventing hospitalisation and death. The authorisation comes at a time when a large percentage of the US population has already received both doses of COVID-19 vaccines and others have received at least one.
The two pharma companies are hoping that their drug is used worldwide as the presence of COVID-19 variants and lagging vaccination rates in other countries give an opportunity for the drug to become useful.
"The fast pace of COVID-19 vaccinations in the US is encouraging, yet despite these aggressive efforts, there is still a need to help prevent infected patients from developing complications,” said Glaxo Chief Scientific Officer Dr Hal Barron.
Cowen & Co. analysts have forecasted that Sotrovimab sales will reach $300 million this year and possibly $500 million in 2022. Such sales figures are important considering the financial capital and investment that went into the development of the drug. Vir’s research and development spending in the first quarter was $134.9 million.
"We put a lot on the line to get this antibody to the place where it is now; we made some big financial commitments for a company of our size,” Vir Chief Executive George Scangos said in an interview.
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