© Reuters. FILE PHOTO: A GlaxoSmithKline (GSK) brand is seen on the GSK analysis centre in Stevenage, Britain November 26, 2019. REUTERS/Peter Nicholls
(Reuters) – European well being regulator mentioned on Thursday it was assessing a advertising and marketing authorisation utility for GSK-Vir Biotechnology’s monoclonal antibody therapy for COVID-19 and will give its opinion inside two months.
The drug, sotrovimab, branded as Xevudy was already beneath a speedy evaluation by the European Medicines Agency (EMA), and GSK’s utility makes the drug the fourth utility at the moment beneath EU lenses for the therapy of COVID-19.
The drug is authorised for emergency use within the United States to forestall delicate or reasonable instances of COVID-19 from worsening. The EMA has given its go-ahead for use by member states however Thursday’s utility would rely for an EU-wide approval, if really helpful by the EMA.
Unlike oral choices from Merck and Pfizer (NYSE:), sotrovimab is given by way of an infusion. Sotrovimab belongs to a category of medicine referred to as monoclonal antibodies which can be lab-generated compounds mimicking the physique’s pure defences.
However, final week GSK and Vir mentioned a examine confirmed the antibody therapy would work when given as a shot within the arm as effectively, doubtlessly providing extra comfort.
The EMA just lately backed comparable antibody therapies from American-Swiss companions Regeneron-Roche and one other from South Korea’s Celltrion, because the area builds up its defence in opposition to surging instances.
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