Medicines regulator approves first monoclonal antibody treatment for COVID-19 in UK

Ronapreve, manufactured by Regeneron and Roche, will be rolled out to NHS patients "as soon as possible".
The government and NHS will confirm how Ronapreve will be deployed to patients

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The first monoclonal antibody (MAB) cocktail has been approved for use in the prevention and treatment of acute COVID-19 in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

Ronapreve, manufactured by Regeneron and Roche, is a cocktail of two monoclonal antibodies: casirivimab and imdevimab.

In a statement on 20 August 2021, the MHRA said that the treatment is administered either by injection or infusion and acts at the lining of the respiratory system where it binds to the SARS-CoV-2 virus, preventing it from entering the cells.

The approval follows a “thorough review” of the evidence by the MHRA and recommendation by the Commission on Human Medicines.

The MHRA statement said that the government and NHS would confirm how the COVID-19 treatment would be deployed to patients “in due course”.

NHS documents seen by The Pharmaceutical Journal in June 2021 revealed that the treatment could be administered to vulnerable patients at home, with pharmacists possibly among the clinicians that assess vulnerable patients for their suitability for treatment with MABs.

The papers also detailed a discussion on “prioritisation of patient cohorts” and noted a “consensus” that this should be based on the potential benefits and risks, with patients that have an impaired immune response or who are unvaccinated prioritised.

Commenting on the approval, health and social care secretary Sajid Javid, said: “The UK is considered a world leader in identifying and rolling out life-saving treatments for COVID-19, once they have been proven safe and effective in our government-backed clinical trials.

“This is fantastic news from the independent medicines regulator and means the UK has approved its first therapeutic designed specifically for COVID-19.

“This treatment will be a significant addition to our armoury to tackle COVID-19 — in addition to our world-renowned vaccination programme and life-saving therapeutics dexamethasone and tocilizumab.

“We are now working at pace with the NHS and expert clinicians to ensure this treatment can be rolled out to NHS patients as soon as possible.”

Raliat Onatade, group chief pharmacist and clinical director for medicines optimisation at Barts Health NHS Trust, told The Pharmaceutical Journal that administration of the MAB cocktail was likely to start “within weeks”, and much like with the COVID-19 vaccines, hospitals had been asked to prepare in anticipation of the MHRA’s approval. 

Onatade said that trusts have been considering “modes of distributions in the community and in in-patients, deciding on the infrastructure [needed] for preparing and administering it”. Following the approval, she added that trusts “can now work on the pharmaceutical elements such as understanding the shelf life and handling instructions”.

“[The] challenges are going to be around administering [the treatment] to people who are COVID-positive,” she explained. “The guidance is that it needs to be administered within 72 hours of them having a positive test,” she continued, adding that the “logistics of getting COVID-positive patients in” to receive treatment needs to be carefully considered.

Regarding the preparation of the treatment, Onatade said that the information had changed from a requirement for it to be prepared in an aseptic unit to advice that it could be prepared using “aseptic technique”, which “is very different”.

“If it only needs to be prepared with aseptic technique, nurses can be trained to do this, as well as pharmacists and pharmacy technicians…what we do know is that it needs to be prepared as close to the patient as possible.”

Regarding administration of the MAB cocktail in the community, Onatade said that, currently, specific hospitals had been nominated to coordinate community administration on behalf of each integrated care system. She also explained that those administering the treatment would be advised as to which patients should be prioritised, and that the decision would not be down to those “at the coal face”.

The MHRA highlighted that clinical trials for the MAB cocktail were conducted before widespread COVID-19 vaccination, and before the emergence of variants of COVID-19. As a result, interpretation of serology was now “more complex”.

It added that it would be for the attending healthcare professional to make a decision on use of the product, taking into account details such as the vaccination status of the patient and local prevalence of COVID-19 variants.

READ MORE: Pharmacists could assess patients’ suitability for COVID-19 monoclonal antibody treatment

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Citation
The Pharmaceutical Journal, PJ, August 2021, Vol 307, No 7952;307(7952)::DOI:10.1211/PJ.2021.1.101594