EU regulator begins real-time review of GSK-Vir COVID-19 antibody drug



© Reuters. FILE PHOTO: A general view outside the Glaxo Smith Kline pharmaceutical company headquarters in West London following the outbreak of the coronavirus disease (COVID-19), London, Britain, May 5, 2020. REUTERS/Toby Melville/File Photo

(Reuters) -Europe’s medicines regulator said on Friday it has begun a real-time review of the COVID-19 antibody treatment developed by GSK and Vir Biotechnology, formally kicking off the process for a potential European Union (EU) approval.

The so-called rolling review comes after the European Medicines Agency (EMA) last month began another review of early data to provide recommendations for national authorities in the trading bloc who may decide on early use of the medicine.

The EMA said it kicked off the real-time review based on early results from an ongoing study into how well the treatment, termed sotrovimab or VIR-7831, can prevent hospitalisation or death in non-hospitalised COVID-19 patients.

“EMA has not yet received the full dataset and it is too early to draw any conclusions regarding the benefit-risk balance of the medicine,” the regulator said https://www.ema.europa.eu/en/news/ema-starts-rolling-review-sotrovimab-vir-7831-covid-19, adding that it has started assessing the first batch of data.

GSK and Vir reported in March that their medicine reduced the risk of hospitalisation and deaths among patients by 85%, based on interim clinical data.

Sotrovimab belongs to a class of medicines called monoclonal antibodies, which are synthetically manufactured copies of the human body’s natural infection-fighting proteins.

It joins similar drugs from Eli Lilly (NYSE:), Celltrion and Regeneron for an EU-rolling review https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/treatments-covid-19/covid-19-treatments-under-evaluation.

Rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data is available.

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