MHRA approve first monoclonal antibody treatment for COVID-19

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ronapreve as the first monoclonal antibody combination product indicated for use in the prevention and treatment of acute COVID-19 infection for the UK. This approval follows a thorough review of the evidence carried out by the MHRH and a recommendation by the Commission on Human Medicine (CHM).

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. Starting in January 2021, a team of MHRA scientists and clinicians assessed clinical trial data which showed that Ronapreve may be used to prevent infection, promote resolution of symptoms in acute COVID-19 infection and reduce the likelihood of being admitted to hospital due to COVID-19.

“This is fantastic news from the independent medicines regulator and means the UK has approved its first therapeutic designed specifically for COVID-19,” said Health and Social Care Secretary, Sajid Javid. “We are now working at pace with the National Health Service (NHS) and expert clinicians to ensure this treatment can be rolled out to NHS patients as soon as possible.”

“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,” added Dr Samantha Atkinson, Interim Chief Quality and Access Officer at MHRA. “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.”

Regeneron/Roche has submitted interim clinical trial reports and the MHRA will receive final study reports in coming months along with the company’s study report of the RECOVERY trial conducted by Oxford University. The government and the NHS will confirm how this COVID-19 treatment will be deployed to patients in due course.

The MHRA emphasised that Ronapreve is not intended to be used as a substitute for vaccination against COVID-19.