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European agency begins fast-track study of experimental Covid treatment
7 May 2021, 16:04
The European Medicines Agency said it had started a rolling review of sotrovimab.
The European Medicines Agency says it has begun an accelerated authorisation process for an experimental coronavirus treatment made by GlaxoSmithKline and Vir BioTechnology.
The EU drug regulator said it had started a rolling review of sotrovimab, based on early results from an ongoing study into whether the treatment can prevent hospital admission or death in people who do not yet have severe Covid-19.
The EMA said it had not yet received the complete data and cautioned it is “too early to draw any conclusions about the benefit-risk balance of the medication”.
Although the agency has approved four vaccines, there are few licensed treatments for coronavirus, especially any that might prevent people with mild Covid-19 from progressing to severe disease.
Sotrovimab is a monoclonal antibody, a lab-produced antibody intended to stimulate the immune system by reducing the ability of coronavirus’s spike protein to enter the body’s cells.
An emergency use authorisation for sotrovimab has also been submitted to regulators in the US and Canada.
Meanwhile, Pfizer has begun the process to earn full US regulatory approval for its vaccine for people aged 16 and older.
That gives Pfizer and German partner BioNTech a chance of winning the first full approval from the US Food and Drug Administration.
The two companies say they have started a “rolling submission” of data from their studies of the two-dose vaccine, first giving the FDA data from laboratory and human testing.
That includes their latest analysis from a key late-stage study that followed the participations for up to six months after they received their second dose.
The companies plan to soon submit data on manufacturing quality controls and the factories making the vaccine.