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GlaxoSmithKline receives US emergency authorisation for COVID-19 treatment

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GlaxoSmithKline PLC (LON:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) have announced the US Food and Drug Administration (FDA) granted emergency use authorisation for their COVID-19 treatment.

Sotrovimab will be used to help adults and paediatric patients aged over 12 with mild-to-moderate symptoms, and who are at high risk for progression to severe COVID-19, including hospitalisation or death.

READ: GlaxoSmithKline emerges as unlikely loser of COVID-19 pandemic – but will a return to normality be enough to sort out trouble?

The monoclonal antibody was analysed in a phase III trial that was stopped early by an independent data monitoring committee in March 2021 after showing profound clinical efficacy.

It demonstrated an 85% reduction in hospitalisation for more than 24 hours or death in those receiving sotrovimab compared to placebo, which was the primary goal.

The most common adverse events were rash and diarrhoea, all of which were mild or moderate.

GSK and Vir said the drug targets a certain part of the virus that is less likely to mutate over time, so it’s effective against the variants currently in circulation, including the Indian one.

The pair also said they are working to make it accessible to “all appropriate patients” in the US, “with little to no out-of-pocket costs”.

The candidate was also recommended by a committee at the European Medicines Agency last week, while Health Canada started a review in April.

Late-stage trials for Sanofi vaccine

In a separate announcement, the FTSE 100 group said and French giant Sanofi said they have started enrolment in their phase III clinical study for their COVID-19 vaccine candidate.

The firms are targeting approval or authorisation in the fourth quarter this year.

The study will include more than 35,000 volunteers aged 18 and older from several countries, including sites in the US, Asia, Africa and Latin America.

The primary goal is the prevention of symptoms and the secondary ones are to prevent severe disease and asymptomatic infection.

It will focus on the original strain and the Brazil variant.

Further study will also assess the candidate as a booster after other kinds of vaccines have been administered.

The phase II of trials showed that the jab achieved high rates of neutralising antibody responses in all adult age groups, with 95 to100% efficacy, while the first dose generated high levels of antibodies, suggesting the potential for boosters.

Shares dipped 1% to 1,341.13p on Thursday morning.

–Adds shares–

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