EMA Initiates Rolling Review of GSK/Vir's Sotrovimab for Early Treatment of COVID-19
GSK
Pharmaceutical R&D Manufacturer
Vir Biotechnology
Developer of Immunological Drugs
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
Compiled by Fan Dongdong
Recently, GlaxoSmithKline and Vir announced that the European Medicines Agency (EMA) has initiated a rolling review of sotrovimab, an early treatment for COVID-19.
Sotrovimab, a therapy for COVID-19 previously known as VIR-7831, is an investigational dual-action monoclonal antibody against SARS-CoV-2. It is indicated for the treatment of adult and adolescent patients (aged 12 years and older, weighing at least 40 kg) who do not require supplemental oxygen but are at high risk of progressing to severe COVID-19. The rolling review process for this COVID-19 antibody therapy has been initiated, indicating that the drug may potentially receive approval from the European Union in the future.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is reviewing data related to sotrovimab. The EMA’s decision to initiate a rolling review was primarily based on interim analysis results of the efficacy and safety data from the Phase 3 COMET-ICE trial.
This Phase 3 trial comparatively evaluated the safety and efficacy of a single intravenous infusion of sotrovimab (500 mg) versus placebo in non-hospitalized patients worldwide. The interim efficacy analysis included 291 patients in the treatment group and 292 patients in the placebo group. Among the study participants, 63% were Hispanic or Latino, and 7% were Black or African American.
The primary efficacy endpoint of the trial was the proportion of patients with progression of COVID-19, defined as those requiring hospitalization for at least 24 hours or dying within 29 days after randomization. An interim analysis of data from 583 randomized patients showed that, compared with placebo (the primary endpoint of the trial), sotrovimab reduced the proportion of patients hospitalized for at least 24 hours or who died by 85% (p=0.002).
Currently, sotrovimab has not been granted marketing authorization in any country or region worldwide. In addition to the European Union, GlaxoSmithKline has also submitted an Emergency Use Authorization (EUA) application for sotrovimab to the U.S. Food and Drug Administration (FDA), while other global regulatory agencies, including Health Canada, are reviewing sotrovimab under expedited review pathways.
Reference source: GSK and Vir Biotechnology Announce the Start of the EMA Rolling Review of VIR-7831 (sotrovimab) for the Early Treatment of COVID-19
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.