The UK medicines regulatory body has approved the first treatment in Britain using man-made antibodies to treat and prevent coronavirus.
According to the Medicines and Healthcare products Regulatory Agency (MHRA), clinical trial data shows that the drug, Ronapreve, may be used for three purposes: to prevent infection, treat symptoms of acute Covid-19 and reduce the likelihood of having to be admitted to hospital.
Clinical trials of Ronapreve took place before vaccination was rolled out across the UK and before the emergence of virus variants such as the Delta variant.
It is the first drug of its kind approved for use in the prevention and treatment of acute coronavirus infection in the UK.
Ronapreve uses monoclonal, or man-made, antibodies that are cloned from white blood cells. They act like naturally produced human antibodies in the immune system to fight the virus.
The drug, which has been developed by pharmaceutical companies Regeneron and Roche, can be administered by injection or infusion.
Health Secretary Sajid Javid said approval of the first drug specifically created to fight Covid-19 in the country is “fantastic news”. He added that he hopes it can be introduced to the NHS for patients “as soon as possible”.
Mr 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.”
MHRA interim chief quality and access officer Dr Samantha Atkinson said: “We are pleased to announce the approval of another therapeutic treatment that can be used 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.”
The drugs regulator said the Government and NHS will announce how the treatment will be given to patients around the UK in due course.