EMA Receives Marketing Authorization Application For Xevudy (sotrovimab) For Treatment Of Patients With COVID-19
The EMA has started to assess a marketing authorization application for the monoclonal antibody Xevudy (sotrovimab). The applicant is GlaxoSmithKline Trading Services Limited, which developed the drug in collaboration with Vir Biotechnology.
Xevudy is for the treatment of adults and adolescents with COVID-19 who do not need additional oxygen therapy and who are at increased risk of progressing to severe COVID-19.
The EMA will assess the benefits and risks of Xevudy within a short timeframe and may issue an opinion within two months, depending on whether the data submitted is sufficiently robust and whether additional information is needed to support the assessment.
Such a short timeframe is only possible because the EMA’s Committee for Medicinal Products for Human Use (CHMP) has already reviewed some data on the medicine during an ongoing review. During this phase, the CHMP assessed the data from laboratory and animal studies, as well as the data on the quality of the medicinal product. In addition, the CHMP assessed data from a study on the effects of sotrovimab in adult outpatients with mild symptoms of COVID-19 who do not need supplemental oxygen and are at increased risk for their disease. getting worse.
In parallel, the EMA Safety Committee (PRAC) completed the preliminary assessment of the risk management plan (RMP) proposed by the company, which describes the measures to identify, characterize and minimize the risks of the drug. In addition, the EMA’s Committee for Medicinal Products for Children (PDCO) has issued its opinion on the company’s Pediatric Investigation Plan (PIP), which outlines how the medicine is to be developed and studied for use in children. , in accordance with the accelerated timelines for COVID-19 products. .
If the additional data now submitted with the Marketing Authorization Application is sufficient for the CHMP to conclude that Xevudy’s benefits outweigh its risks in treating COVID-19, the EMA will work closely with the European Commission to speed up the decision to grant a marketing authorization. in all EU and EEA member states.
EMA will communicate further at the time of CHMP opinion.
How the medicine should work:
Sotrovimab (also known as VIR-7831 and GSK4182136) is a monoclonal antibody with activity against COVID-19. A monoclonal antibody is a type of protein that attaches to a specific structure (called an antigen). Sotrovimab is designed to bind to the spike protein of SARS-CoV-2, the virus that causes COVID-19. When it attaches to the spike protein, the ability of the virus to enter body cells is reduced. This is expected to reduce the severity of the disease and the need for hospitalization in patients with COVID-19.