EU starts rolling review of GSK’s antibody for COVID-19

The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU. 

Sotrovimab (VIR-7831) – also known as GSK4182136 – is being assessed as a treatment for patients with SARS-CoV-2 infection aged 12 and over who do not require oxygen supplementation and are at risk of progressing to severe COVID-19.

The antibody is also being evaluated for emergency use in these patients in the EU as well as the US and Canada, but this is the first time that GSK and Vir have moved ahead with a full marketing application.

The EMA has already backed emergency use of three other anti-SARS-CoV-2 antibodies – Regeneron’s casirivimab/imdevimab (REGN-COV2), Eli Lilly’s bamlanivimab/etesevimab and Celltrion’s regdanvimab – to protect high-risk COVID-19 patients.

All of these antibodies have also started the rolling review process at the EMA, which involves stepwise evaluation of data as it becomes available and is designed to shorten the overall time to a decision on approval.

The EMA says the decision to start the rolling review is based on preliminary results from the ongoing COMET-ICE study which found that sotrovimab was able cut the risk of hospitalisation for more than 24 hours or death by 85% compared to placebo in non-hospitalised patients with COVID-19.

At the moment the regulator is looking at the first batch of data from lab and animal studies as well as quality studies. Other data such as final clinical trial results will be assessed in due course.

Like the other antibodies, sotrovimab is designed to attach to the spike protein of SARS-CoV-2, limiting the ability of the virus to enter the body’s cells.

Vir and GSK have previously said that its drug – derived from antibodies taken from COVID-19 survivors – has a dual action, both blocking the virus from infecting new cells and recruiting the immune system to eliminate already-infected cells.

This dual action could differentiate sotrovimab from the other anti-SARS-CoV-2 antibodies, according to GSK’s R&D chief Hal Barron. GSK and Vir also say that resistance to sotrovimab is unlikely to develop as it targets part of the spike protein that rarely mutates.

Intramuscular injection

The two partners are also pushing hard to see if the antibody can be administered by intramuscular injection rather than intravenously, which could make it possible to administer the treatment outside hospital. All the other antibodies are so far also delivered by IV infusion.

In addition to the COMET-ICE trial, GSK and Vir are running or planning up three other studies of the antibody, including an ongoing phase 2 trial called COMET-PEAK that is comparing an IM injection to IV administration.

Two phase 3 trials of the IM formulation will follow in the coming weeks. COMET-TAIL will be carried out in high-risk COVID-19 patients, while COMET-STAR will assess whether sotrovimab can prevent infection in people who are uninfected with SARS-CoV-2.

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