GSK presenta in EMA la richiesta di autorizzazione alla commercializzazione di Xevudy (sotrovimab) per il trattamento del COVID-19

EMA has officially started evaluating the marketing authorization application for GSK's Xevudy (sotrovimab) for the treatment of adults and adolescents with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19.

EMA will assess the benefits and risks of Xevudy under a reduced timeline and could issue an opinion within two months, depending on whether the data submitted are sufficiently robust and whether further information is required to support the evaluation. 

As a reminder, EMA had initiated a rolling review of Xevudy back in May 2021 as well as completed an Article 5(3) review to provide a harmonised scientific opinion at EU level to support national decision-making on the possible use of the antibody prior to marketing authorisation.

During this phase, the CHMP assessed data from laboratory studies and animal studies, as well as data on the quality of the medicine. In addition, the CHMP assessed data from a study into the effects of sotrovimab in adult outpatients with mild COVID-19 symptoms who do not need supplemental oxygen and who are at increased risk of their disease becoming severe.

Fonte: EMA press release