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23 June, 2021
 
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EMA puts COVID pill review on fast track

European Commissioner Stella Kyriakides says therapeutic solutions alongside vaccinations remain crucial

Newsroom

The European Medicines Agency says it has begun a rolling review of data on sotrovimab, an antibody cure for treating COVID-19, with European Commissioner Stella Kyriakides saying therapeutic solutions were also crucial alongside vaccinations.

According to EMA, its human medicines committee said it has begun an accelerated authorization process for an experimental coronavirus treatment made by GlaxoSmithKline and Vir BioTechnology.

EMA has not received a full dataset, saying it was 'too early to draw any conclusions about the benefit-risk balance of the medication'

In a statement on Friday, the EU drug regulator said it had started a “rolling review” of sotrovimab, essentially a fast track process with IRB oversight and human subject protection, based on early results from an ongoing study into whether the treatment can prevent hospitalization or death in people who don’t yet have severe COVID-19.

A rolling review is expected to allow EMA to hit the ground running by gaining valuable time before EU compliance is put to the test, with reports saying a similar emergency use authorization for sotrovimab has also been submitted to regulators in the US and Canada.

But EMA said it had not received a full dataset and further cautioned it was “too early to draw any conclusions about the benefit-risk balance of the medication.”

Kyriakides confirmed on Twitter that EMA started evaluating the monoclonal antibody sotrovimab, which is a lab-produced antibody that is intended to stimulate the immune system by reducing the ability of the coronavirus’s spike protein to enter the body’s cells.

In a survey released last week, about 23% of people polled in the US said they did not want to be jabbed with a COVID-19 vaccine, but about one-third of those said they would take a vaccine tablet if it were available.

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