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GSK, Vir’s COVID-19 mAb scores FDA emergency use approval

Interim phase 3 trial results found sotrovimab reduced the risk of hospitalisation or death by 85% compared to placebo

GlaxoSmithKline (GSK) and Vir Biotech’s COVID-19 monoclonal antibody (mAb) sotrovimab has been granted an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).

The EUA clears sotrovimab – previously known as VIR-7831 – for the treatment of mild-to-moderate COVID-19 in high-risk adults and certain paediatric patients who have a positive SARS-CoV-2 test.

Interim trial results from a phase 3 trial evaluating the mAb found that sotrovimab reduced the risk of hospitalisation for more than 24 hours or death by 85% compared to placebo.

An analysis of safety and efficacy data for the full population from this trial – named COMET-ICE – is expected in the first half of 2021.

In addition to the positive phase 3 results, GSK and Vir said results from a new study – submitted to the pre-print server bioRxiv – demonstrating that VIR-7831 maintains activity against currently circulating ‘variants of concern’. This includes the variants discovered in the UK, South Africa and Brazil.

The results are based on in vitro data from pseudotyped virus assays – according to GSK/Vir, their mAb binds to a highly conserved epitope of the spike protein, which could make it more difficult for resistance to develop.

“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 Hal Barron, chief scientific officer and president R&D at GSK.

“In just over a year since starting our collaboration and in less than ten months since beginning clinical trials, we are delighted that, as of today, the benefits of this unique monoclonal antibody will now be available to patients in need,” he added.

Earlier this week, the European Medicines Agency (EMA) issued advice for the use of sotrovimab for the treatment of COVID-19.

Following a review of the mAb, the EMA concluded that the sotrovimab can be used to treat high-risk COVID-19 patients.

The agency’s advice can be used to support national advice for European Union member states on the potential use of the mAb prior to a marketing authorisation for the treatment.

The EMA also announced earlier this month that it had launched a rolling review of VIR-7831, based on the interim analysis of data from the phase 3 COMET-ICE trial.

Article by
Lucy Parsons

28th May 2021

From: Regulatory



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