Filenews 21 May 2021
The Committee on Medicinal Products for Human Use of EMA (CHMP) has completed its review of the use of the monoclonate antibody sotrovimab (also known as VIR-7831 and GSK4182136) for the treatment of patients with COVID-19. This review was carried out to provide a harmonised scientific opinion at EU level in support of national decision-making on the possible use of the antibody prior to marketing authorisation.
The Agency concluded that sotrovimab can be used to treat confirmed COVID-19 in adults and adolescents (aged 12 years and over and weighing at least 40 kg) who do not need additional oxygen therapy and who are at risk of progressing to severe COVID-19.
The drug is given by infusion (drip) into a vein and the recommended conditions of use are available.
The EMA made its recommendations after a review of the data, including quality data and a study on the effects of sotrovimab on adult outpatients with mild COVID-19 symptoms that do not need supplemental oxygen. A planned interim analysis of this study showed that sotrovimab reduced the risk of hospitalization for more than 24 hours or death by 85% compared to placebo: hospitalization for more than 24 hours or death occurred in 1% (3 out of 291) of patients treated with sotrovimab and 7% (21 out of 292) of those taking placebo.
In terms of safety, most of the side effects reported were mild or moderate. Infusion-related reactions (including allergic reactions) cannot be excluded and health professionals should monitor patients for these reactions.
Ema recommendations can now be used to support national advice on the possible use of this monoclonate before a marketing authorisation is issued.
While the current evaluation is complete, a rolling review of sotrovimab, which began on May 7, continues. Once finalised, the rolling review will form the basis for an APPLICATION for an EU marketing authorisation for this medicine.
More about the drug
Sotrovimab (also known as VIR-7831 and GSK4182136) is a monoclonate antibody active against SARS-CoV-2, the virus that causes COVID-19. A monoclonate antibody is a type of protein that attaches to a specific structure (called an antigen). Sotrovimab is designed to attach to the protein spike of SARS-CoV-2, limiting the virus's ability to enter the body's cells.
More about the process
The review of Sotrofimab was initiated at the request of the Executive Director n accordance with Article 5(3) of Regulation No 726/2004 following a preliminary discussion with the COVID-19 EMA Pandemic Task Force (COVID-ETF), which brings together experts from across the European Medicines Regulatory Network for development advice, the authorisation and monitoring of the safety of medicinal products and vaccines for COVID-19.
The review of Sotrovimab was carried out by the EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions about medicinal products for human use, which has now issued its scientific opinion. The scientific opinion of the CHMP may be taken into account by the EU Member States and the EMA in the evaluation of this medicine for the treatment of COVID-19.
