The EMA evaluates approval of the monoclonal antibody sotrovimab for COVID-19

The European Medicines Agency (EMA) received on Thursday a request from the British pharmaceutical company GlaxoSmithKline to evaluate the European license of the monoclonal antibody Xevudy (sotrovimab) as a treatment for adults and adolescents at risk with COVID-19 who do not need additional oxygen.

The agency today began evaluating the application for GlaxoSmithKline, which developed the drug together with the American For Biotechnology, and that it is indicated to treat COVID-19 in adults and adolescents who do not require supplemental oxygen therapy and who have an increased risk of developing the disease in its serious condition.

The Committee for Human Medicines (CHMP) began a process of continuous review of this drug last May, analyzing in real time all the data that has emerged on this treatment, which now allows it to evaluate the benefits and risks of Xevudy for the license in a shorter term, having advanced work during the last months.

During this phase, the CHMP evaluated data from laboratory and animal studies, as well as data on drug quality, and from a study on the effects of sotrovimab in at-risk adult outpatients with mild symptoms of COVID-19 they do not need supplemental oxygen.

The agency could issue an opinion “Within two months, depending on whether the data presented is strong enough and if more information is required to support the assessment”.

The opinion reached by the EMA It will be communicated to the European Commission, which, if it receives a positive resolution, has the last word on the issuance of the license that will allow developers to use their drug in European countries.

In addition to Xevudy, the EMA was already analyzing the possible license of Olumiant (baricitinib), a licensed drug for rheumatoid arthritis that could be used to treat COVID-19 in hospitalized patients requiring oxygen therapy.

A license has also been applied for the immunosuppressant Kineret (anakinra), already authorized to treat inflammatory diseases; and the anti-inflammatory tocilizumab (RoActemra), also used to treat rheumatoid arthritis.

Two others are in a continuous review phase: the drug Evusheld, a combination of antibodies tixagevimab and cilgavimab developed by AstraZeneca AB; and the antiviral molnupiravir, which is administered orally, developed by the American pharmaceutical company Merck Sharp & Dohme in collaboration with the biotechnology company Ridgeback Biotherapeutics.