© Reuters. FILE PHOTO: A GlaxoSmithKline (GSK) emblem is seen on the GSK analysis middle in Stevenage, Britain November 26, 2019. REUTERS/Peter Nicholls
(Reuters) – European well being regulator mentioned on Thursday it was assessing a advertising authorization software for GSK-Vir Biotechnology’s monoclonal antibody remedy for COVID-19 and will give its opinion inside two months.
The drug, sotrovimab, branded as Xevudy was already underneath a speedy overview by the European Medicines Company (EMA), and GSK’s software makes the drug the fourth software presently underneath EU lenses for the remedy of COVID-19.
The drug is allowed for emergency use in america to stop delicate or reasonable circumstances of COVID-19 from worsening. The EMA has given its go-ahead to be used by member states however Thursday’s software would rely for an EU-wide approval, if advisable by the EMA.
Not like oral choices from Merck and Pfizer (NYSE:), sotrovimab is given through an infusion. Sotrovimab belongs to a category of medicine often known as monoclonal antibodies which are lab-generated compounds mimicking the physique’s pure defenses.
Nevertheless, final week GSK and Vir mentioned a examine confirmed the antibody remedy would work when given as a shot within the arm as effectively, probably providing extra comfort.
The EMA not too long ago backed comparable antibody therapies from American-Swiss companions Regeneron-Roche and one other from South Korea’s Celltrion, because the area builds up its protection in opposition to surging circumstances.
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