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Access to anti-Covid monoclonal antibody therapy Ronapreve

As outlined in a Special Edition of the Newsletter (April 2021), monoclonal antibodies (mAbs) offer a novel approach to the prevention and the treatment of COVID-19 infections, especially in patients at increased risk of severe disease such as patients with immunodeficiencies, in whom a COVID-19 vaccine has limited or no effectiveness.

Immunodeficiency UK welcomed the news late August 2021 of the UK approval (licence) of Ronapreve by the Medicines and Healthcare products Regulatory Agency (MHRA) as the first monoclonal antibody combination product for use in the prevention (prophylaxis) and treatment of acute COVID-19 infection.

Ronapreve is supplied to the UK by Roche. It is a combination neutralising monoclonal antibody (casirivimab plus imdevimab) used to inhibit viral replication in individuals who have not yet mounted an adequate antibody response to the SARS-COV-2 virus following either exposure or vaccination.

On 17th September 2021, the UK government announced that this new medicine will be available across all four nations from the following week, initially for patients in hospital with no antibody response against COVID-19, "either aged 50 and over, or aged 12 to 49 and are considered to be immunocompromised". The government have assured that there will be sufficient supply to treat these patients in all the UK home nations.

To gain access to the new treatment, hospitalised, immunocompromised patients will need to undergo antibody testing to check that they do not have any antibodies (i.e. they are seronegative) against COVID-19.  If that is the case, they will receive Ronapreve.

Here you can find the interim clinical commissioning policy and the therapeutic alert concerning this treatment. The latter contains information on the results of the use of Ronapreve in patients in the Recovery clinical trial.

The patient information leaflet can be found here

Please note: Ronapreve is NOT available for prophylactic use to PREVENT Covid infection.  This is something that Immunodeficiency UK will be lobbying for.

Other mAbs have been undergoing clinical trials and it is hoped that their approval for similar indications as Ronapreve will follow in the coming months.

Related link: https://www.gov.uk/government/news/thousands-of-patients-to-benefit-from-life-saving-covid-19-treatment

This article was written by Valerie Brisse-Uhlig, a volunteer for Immunodeficiency UK, and was approved by the Chair of the Immunodeficiency UK Medical Panel.

Posted 23rd September 2021