A drug containing man-made antibodies that fight and prevent Covid-19 has been approved by the medicines regulator for use in the UK.
The Medicines and Healthcare products Regulatory Agency (MHRA) said clinical trials had shown the drug may be used to prevent infection, treat symptoms of acute coronavirus infection and can reduce the likelihood of being admitted to hospital with the virus.
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At a glance: 5 key points
- The drug, called Ronapreve, has been developed by pharmaceutical firms Regeneron and Roche and can be administered either by injection or infusion.
- The MHRA said the drug acts at the lining of the respiratory system where it binds tightly to the virus, thereby preventing it from gaining access to the cells.
- It is the first monoclonal antibody combination drug to be approved for use in the prevention and treatment of acute infection from Covid-19 in the UK.
- Ronapreve contains monoclonal antibodies, which are man-made proteins that act like natural human antibodies in the immune system.
- Clinical trials of the drug took place before widespread vaccination rolled out and before the emergence of coronavirus variants, including the highly infectious Delta variant.
What’s been said
Health Secretary Sajid Javid described the approval of Ronapreve in the UK as “fantastic news” and said it will hopefully be available for patients on the NHS soon.
He 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.”
MHRA interim chief quality and access officer Dr Samantha Atkinson said the drug is the “first of its kind” for the treatment of coronavirus and its approval means many lives can be saved.
She added: “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.”
The regulator said the government and NHS will confirm how the treatment will be deployed to patients in due course.
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