EMA to begin review of GSK and Vir’s COVID-19 treatment

pharmafile | April 16, 2021 | News story | Medical Communications COVID-19, EMA, GSK, covid-19 treatment, pharma, pharma news, vir 

The EMA have begun a review of GSK and Vir Biotechnology’s investigational COVID-19 antibody (VIR-7831) for patients at high risk of progressing to a severe form of the virus.

The review is being carried out by the EMA’s Committee for Human Medicinal Products (CHMP), and will provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorisation Application (MAA).

A decision will be partly based on data from the randomised Phase III COMET-ICE trial of 583 participants at high risk of being hospitalised. Interim analysis of the study has shown an 85% reduction in hospitalisation or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial. 

It was recommended by the Independent Data Monitoring Committee that the study be stopped early due to ‘evidence of profound efficacy’.

The Australian Therapeutic Goods Administration granted a provisional determination of the treatment earlier this week, while an Emergency Use Authorization has also been submitted to the FDA in the US by GSK and Vir. 

As yet, the drug has not been granted a marketing authorisation anywhere, but GSK is planning to submit a full MAA to the EMA, which will include the data from the COMET-ICE trial.

Preclinical data suggest VIR-7831 targets a highly conserved epitope of the COVID-19 spike protein, which may make it more difficult for resistance to develop. Data published in bioRxiv also suggest the treatment maintains activity against current circulating variants, including the UK, South African, Brazilian, and Californian strains.

Vir and GSK entered into a collaboration in April last year, using GSK’s expertise in functional genomics, and Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. The two companies are also working on a vaccine together.

Jack Goddard

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