The Medicines and Healthcare products Regulatory Agency (MHRA) said, following on from its thorough review of the evidence and the recommendation by the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body, it has approved Ronapreve for use in the prevention and treatment of acute COVID-19 infection.
Co-developed by Regeneron and Roche, the drug consists of two monoclonal antibodies, casirivimab and imdevimab. It 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.
The drug is not intended to be used as a substitute for vaccination, the MHRA said.
The MHRA said clinical trial data assessed by its 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 the coronavirus.
Regeneron/Roche submitted interim clinical trial reports and the MHRA said it expects to receive final study reports in coming months along with the report from the RECOVERY trial conducted by Oxford University.
UK health and social care secretary, Sajid Javid, said the treatment will be a significant addition to the country’s armory to tackle COVID-19 in addition to vaccination and the 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.”