EMA has started an ongoing review of Vir Biotechnology and GSK against COVID-19
The European Medicines Agency (EMA) has started a continuous review of sotrovimab (monoclonal antibody VIR-7831) developed by Vir Biotechnology and GSK for the treatment of COVID-19 patients, the Agency announced. The Committee for Medicinal Products for Human Use (CHMP) EMA has initiated an ongoing review of data on sotrovimab (also known as VIR-7831 and GSK4182136), a monoclonal antibody developed by GlaxoSmithKline and Vir Biotechnology Inc. for the treatment of COVID-19.
The decision to initiate continuous review is based on the preliminary study results showing a reduction in potential hospitalizations or deaths in COVID-19 patients, also reported. EMA has started evaluating a first batch of data that comes from laboratory and animal studies. The EMA will evaluate all data on the medicine, including evidence from clinical trials, when available. The continuous review will continue until there is sufficient evidence to support a formal application for a marketing authorization.
The Agency notes that it has not yet received the full range of data and that it is too early to draw any conclusions on the benefit-risk balance for this medicine.
EMA has announced that it will assess the drug's compliance with EU standards for efficacy, safety and quality. While the overall timing of the review cannot be foreseen yet, the process should be faster than a normal assessment due to the time gained during the continuous review.
Continuous review is a regulatory tool that EMA uses to speed up the evaluation of a promising drug or vaccine in a public health emergency.
VIR-7831 (GSK4182136) is a monoclonal antibody active against SARS-CoV-2, the virus that causes COVID-19. A monoclonal antibody is a type of protein that attaches to a specific structure (called an antigen). VIR-7831 is designed to attach to the SARS-CoV-2 spike protein, reducing the virus's ability to enter cells in the body. The drug is expected to reduce the need for hospitalization in COVID-19 patients.
Nearly a month ago, Vir Biotechnology and GlaxoSmithKline announced that the Independent Data Monitoring Committee has recommended stopping recruitment for the phase III COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial evaluating VIR-7831 (GSK4182136) monotherapy in the early phase of COVID-19 treatment in adults at high risk of hospitalization, due to data showing high efficacy. As GSK reported at the time, the IDMC recommendation is based on the results of a preliminary analysis of 583 patients enrolled in the COMET-ICE study, indicating 85% of patients. reduction in the rate of hospitalization or death among patients receiving VIR-7831 compared to placebo.
Based on these results, Vir and GSK have announced that they plan to immediately apply for an Emergency Marketing Authorization (EUA) from the US Food and Drug Administration (FDA) and for marketing authorizations in other countries. The data from this registration study will also form the basis of a drug approval application to the FDA, it has indicated.
At the same time, the companies announced at the time that the results of a new study, reported and pending online in the journal bioRxiv, indicated that "the product VIR-7831 is active against currently circulating significant variants of the virus, including the British, South African and Brazilian variants, as indicated by in vitro data from viral tests ".
Source: EMA and ISBnews