Monoclonal antibodies for COVID-19 in the pipeline

This article aims to update you on the status of medicine approval of monoclonal antibodies (Mabs) and other treatments for Covid-19. 

The information below gives a comparison of the current and expected approval status for mAbs for COVID-19 in the UK (Medicines and Healthcare products Regulatory Agency - MHRA), European Union (European Medical Agency - EMA) and USA (Food and Drug Administration - FDA). This is a snapshot of the situation on 17th September 2021.

Health agencies have been using 'rolling reviews' and 'evaluations of marketing authorisation applications' to assess COVID-19 treatments. A rolling review speeds up the evaluation of a promising medicine or vaccine during a public health emergency.

You can find out more about the process of medicine approval here.

Medicine name: Bamlanivimab and etesevimab (Antibody combination and bamlanivimab used alone).

These are neutralising mAbs that bind to different, but overlapping, epitopes in the spike protein of Covid-19 (SARS-CoV-2).

UK (MHRA): Status unknown
EU (EMA): Under rolling review - 11/3/2021; Advice from review completed on 5 Mar 2021.
USA (FDA): Emergency use authorisation. Used for treatment: Feb. 2021; Post-exposure prevention (prophylaxis): Sept. 2021

Medicine name: REGN-COV2 (casirivimab / imdevimab) (Antibody combination)

REGN-COV2/Ronapreve is made up of two monoclonal antibodies (REGN10933 and REGN10987) that bind non-competitively with the Covid-19 virus.

UK (MHRA): 19/8/2021: Conditional Marketing Authorisation granted with an indication for use in the prevention and treatment of acute COVID-19 infection for the UK. Currently only being used for treatment. 
EU (EMA): Rolling review started 1/2/2021. Review completed. The agency concluded that REGN-COV2 can be used for the treatment of confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.
USA (FDA): Emergency use authorisation. Used for treatment: Nov. 2020; Post-exposure prevention (prophylaxis): July 2021.

Medicine name: Regdanvimab

Regdanvimab works by binding to a specific target on the SARs-CoV-2 virus - the spike receptor binding domain protein - and flags it as 'foreign' so that other parts of the immune system can help to clear it away.

UK (MHRA): Status unknown.  
EU (EMA): Rolling review started 24/2/2021.  The EMA's Committee on Human Medicinal Product (CHMP) completed its review on 26 Mar 2021 on regdanvimab to treat patients with COVID-19. It concluded that regdanvimab can be used for the treatment of confirmed COVID-19 in adult patients who do not require supplemental oxygen therapy and who are at high risk of progressing to severe COVID-19.
USA (FDA): Status unknown.

Medicine name: Sotrovimab

Sotrovimab targets a conserved part of the spike protein that is less likely to mutate over time.

UK (MHRA): Status unknown.
EU (EMA): Rolling review started 7/5/21. EMA has now completed the review.
USA (FDA): Emergency use authorisation, May 2021.

Medicine name:  Tocilizumab

This is considered a potential treatment for COVID-19 because of its ability to block the action of interleukin-6, a substance produced by the body‚Äôs immune system in response to inflammation, which plays an important role in COVID-19. 

UK (MHRA): An interim position statement was produced Jan. 2021 and an Interim Clinical Commissioning Policy: IL-6 inhibitors (tocilizumab or sarilumab) for hospitalised patients with COVID-19 (adults) published 12 September 2021.
EU (EMA): On 16 August 2021 EMA started an accelerated assessment  to decide whether to extend its use to include treatment of hospitalised adult patients with severe COVID-19 who are already receiving treatment with corticosteroids and require extra oxygen or mechanical ventilation. Decision expected October 2021.
USA (FDA): Emergency use authorisation, June 2021.

Related links

Anti-SARS-CoV-2 Monoclonal Antibodies | COVID-19 Treatment Guidelines (nih.gov)

COVID-19 vaccines and treatments, regulatory status at a glance 1 of 2 - Pharmavibes

This article was written by Valerie Brisse-Uhlig, a volunteer for Immunodeficiency UK, and Dr Susan Walsh. It was approved by the Chair of the Immunodeficiency UK Medical Panel.  Posted October 2021