EU regulator examines new COVID-19 drug Xevudy
European Medicines Agency evaluates if antibody treatment to reduce severity of COVID-19 can be marketed in EU
By Agnes Szucs
BRUSSELS (AA) – The European Medicines Agency (EMA) started to evaluate if COVID-19 antibody therapy Xevudy can be authorized in the EU, the institution announced on Thursday.
“EMA will assess the benefits and risks of Xevudy under a reduced timeline and could issue an opinion within two months,” the EU agency wrote in a press statement.
Xevudy, developed by pharma companies GlaxoSmithKline and Vir Biotechnology, “is expected to reduce the severity of the disease and the need for hospitalization in patients with COVID-19,” the EMA explained.
The drug is meant to treat adults and teenagers who are at increased risk of progressing to severe COVID-19 but do not yet require supplemental oxygen.
The treatment is based on a monoclonal antibody therapy using a type of protein that attaches to the spike of the virus that causes COVID-19 and reduces its ability to enter the human body’s cell.
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