US FDA authorises GSK-Vir monoclonal antibody drug for COVID

The US Food and Drug Administration (FDA) has authorised a monoclonal antibody drug against COVID-19, developed by GlaxoSmithKline and Vir, which claims to reduce hospitalisation and death among Coronavirus patients by 85 per cent and is also effective against the variants.

The drug Sotrovimab has been given an emergency use authorisation (EUA) for the treatment of mild-to-moderate COVID-19 in adults and children 12 years of age and older, weighing at least 40 kg.

The drug has shown positive results among patients 65 years of age and older or individuals who have certain medical conditions and are at high risk for progression to severe Covid-19, including hospitalisation or death.

Laboratory tests have shown that Sotrovimab is able to neutralise the current circulating variants of Covid first reported in the UK, South Africa, Brazil, California, New York and India.

"With the authorisation of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with Covid-19 out of the hospital," Patrizia Cavazzoni, Director of the FDA's Center for Drug Evaluation and Research, said in a statement on Wednesday.

"It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of Covid-19 in the United States," Cavazzoni added.

However, Sotrovimab is not authorised for patients who are hospitalised due to Covid-19 or require oxygen therapy due to the disease, the FDA said.

This treatment has not shown benefit in patients hospitalised due to Covid-19 and monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalised patients requiring high flow oxygen or mechanical ventilation.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens such as viruses. 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 EUA is based on an interim analysis from a Phase 1/2/3 randomised, double-blind, placebo-controlled clinical trials in 583 non-hospitalised adults with mild-to-moderate Covid-19 symptoms and a positive SARS-CoV-2 test result.

Of these patients, 291 received Sotrovimab and 292 received a placebo within five days of onset of Covid-19 symptoms. The primary endpoint was progression of Covid-19 (defined as hospitalisation for greater than 24 hours for acute management of any illness or death from any cause) through day 29.A

Hospitalisation or death occurred in 21 (7 per cent) patients who received placebo compared to 3 (1 per cent) patients treated with Sotrovimab, an 85 per cent reduction.

The drug will be distributed and administered as a 500 milligram single dose intravenously by health care providers. Potential side effects of Sotrovimab include anaphylaxis and infusion-related reactions, rash and diarrhoea, the FDA said.