EMA CHMP Recommends Sotrovimab for Early Treatment of COVID-19 with Demonstrated Efficacy Against Multiple Variants
GSK
Pharmaceutical R&D Manufacturer
Vir Biotechnology
Developer of Immunological Drugs
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
On May 21, 2021, GlaxoSmithKline and Vir Biotechnology announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the COVID-19 neutralizing antibody therapy sotrovimab, supporting its approval for the treatment of adults and adolescents who do not require supplemental oxygen but are at risk of progressing to severe COVID-19. Sotrovimab is an investigational monoclonal antibody targeting a conserved epitope of the SARS-CoV-2 spike protein. Preclinical data indicate that it can not only block viral entry into healthy cells but also clear virus-infected cells.
The positive opinion issued by the CHMP on sotrovimab is based on a review of data from multiple trials of the drug. This includes an analysis of data from the multicenter, randomized, double-blind Phase 3 COMET-ICE clinical trial, which evaluated the efficacy and safety of sotrovimab as monotherapy for early COVID-19 in adults at high risk of hospitalization. Based on interim data from 583 patients, sotrovimab met the trial’s primary endpoint, demonstrating an 85% reduction in the risk of hospitalization or death due to COVID-19 progression compared with the control group (p=0.002). Additionally, the CHMP considered relevant data regarding the quality and safety of the drug.
As the COVID-19 pandemic continues and SARS-CoV-2 continuously generates new variants, the CHMP has also reviewed data from several in vitro studies. Data from live-virus and pseudovirus in vitro assays indicate that sotrovimab retains activity against multiple circulating variants of concern, including the P.1 variant first identified in Brazil, the B.1.427/B.1.429 variant identified in California, USA, the B.1.351 variant identified in South Africa, and the B.1.1.7 variant identified in the UK. Studies recently published on preprint servers further demonstrate that it retains activity against the B.1.526 variant first identified in New York and the B.1.617 variant identified in India.
Dr. George Scangos, Chief Executive Officer of Vir, stated: “CHMP’s support is good news for patients, as it now enables EU member states to more readily advance the use of sotrovimab through temporary authorization. Based on our latest in vitro data, sotrovimab retains activity against all currently circulating SARS-CoV-2 variants of concern. We look forward to continuing to collaborate with regulatory agencies worldwide to expand access to sotrovimab for patients in need and to help end this pandemic.”
References:
[1] EMA Issues Positive Scientific Opinion on GSK and Vir Biotechnology’s Sotrovimab For the Early Treatment of COVID-19. Retrieved May 21, 2021, from https://investors.vir.bio/news-releases/news-release-details/ema-issues-positive-scientific-opinion-gsk-and-vir
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