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Monoclonal antibody treatment for COVID-19 approved for use

The Medicines and Healthcare products Regulatory Agency (MHRA) has given approval for the first monoclonal antibody treatment for the prevention and treatment of COVID-19 in the UK.

Following on from a thorough review of the evidence carried out by the MHRA, and recommendation by the Commission on Human Medicines (CHM), Ronapreve has been approved for use in the prevention and treatment of acute COVID-19 infection in the UK.

Developed by Regeneron/Roche, the drug is administered either by injection or infusion and acts at the lining of the respiratory system where it binds tightly to the coronavirus and prevents it from gaining access to the cells of the respiratory system. Clinical trial data assessed by a dedicated team of MHRA scientists and clinicians has shown that Ronapreve may be used to prevent infection, promote resolution of symptoms of acute COVID-19 infection and can reduce the likelihood of being admitted to hospital due to COVID-19.

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.

Interim Chief Quality & Access Officer, Dr Samantha Atkinson said: "We are pleased to announce the approval of another therapeutic treatment that can be used for to help save lives and protect against COVID-19. Ronapreve is the first of its kind for the treatment of COVID-19, and after a meticulous assessment of the data by our expert scientists and clinicians, we are satisfied that this treatment is safe and effective.

"With no compromises on quality, safety and efficacy, the public can trust that the MHRA have conducted a robust and thorough assessment of all the available data."

 

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Upcoming Events

IPS 2021

ACC Liverpool
27th - 29th September

The Operating Theatres Show 2021

Hilton Metropole Hotel, London
7th October

Future Surgery 2021

ExCel London
9th - 10th November 2021

Medica 2021

Dusseldorf Germany
15th - 18th November

Arab Health 2022

Dubai World Trade Centre
24th - 27th January

Central Sterilising Club 60th Anniversary Annual Scientific Meeting

Crowne Plaza, Bridge Foot, Stratford-upon-Avon, CV37 6YR
4th - 5th April

Access the latest issue of Clinical Services Journal on your mobile device together with an archive of back issues.

Download the FREE Clinical Services Journal app from your device's App store

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