The MHRA has given approval for the first monoclonal antibody treatment for the prevention and treatment of coronavirus in the UK.
Developed by Regeneron/Roche, the Ronapreve 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 coronavirus infection and can reduce the likelihood of being admitted to hospital due to coronavirus.
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.”