EU assesses GSK-Vir COVID-19 antibody therapy for authorisation

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By Reuters
EU assessing GSK-Vir monoclonal antibody for COVID-19 treatment
EU assessing GSK-Vir monoclonal antibody for COVID-19 treatment   -   Copyright  Thomson Reuters 2021   -  

<div> <p> -European health regulator said https://www.ema.europa.eu/en/news/ema-receives-application-marketing-authorisation-xevudy-sotrovimab-treating-patients-covid-19 on Thursday it was assessing a marketing authorisation application for <span class="caps">GSK</span>-Vir Biotechnology’s monoclonal antibody treatment for <span class="caps">COVID</span>-19 and could give its opinion within two months.</p> <p>The drug, sotrovimab, branded as Xevudy was already under a speedy review by the European Medicines Agency (<span class="caps">EMA</span>), and <span class="caps">GSK</span>’s application makes the drug the fourth application currently under EU lenses for the treatment of <span class="caps">COVID</span>-19.</p> <p>The drug is authorised for emergency use in the United States to prevent mild or moderate cases of <span class="caps">COVID</span>-19 from worsening. The <span class="caps">EMA</span> has given its go-ahead for use by member states but Thursday’s application would count for an EU-wide approval, if recommended by the <span class="caps">EMA</span>.</p> <p>Unlike oral options from Merck and Pfizer, sotrovimab is given via an infusion. Sotrovimab belongs to a class of drugs known as monoclonal antibodies that are lab-generated compounds mimicking the body’s natural defences. </p> <p>However, last week <span class="caps">GSK</span> and Vir said a study showed the antibody treatment would work when given as a shot in the arm as well, potentially offering more convenience.</p> <p>The <span class="caps">EMA</span> recently backed similar antibody therapies from American-Swiss partners Regeneron-Roche and another from South Korea’s Celltrion, as the region builds up its defence against surging cases. </p> </div>