UK regulator approves antibody drug Ronapreve to prevent, tackle COVID-19

The UK’s medicines regulator approved the medical use of the country’s first drug made by using man-made antibodies to prevent and treat COVID-19.

Ronapreve is the first monoclonal antibody combination product indicated for use in the prevention and treatment of acute COVID-19 infection for the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) said.

Monoclonal antibodies are man-made proteins that act like natural human antibodies in the immune system.

“This is fantastic news from the independent medicines regulator and means the UK has approved it’s first therapeutic designed specifically for COVID-19,” said UK Health Secretary Sajid Javid.

“This treatment will be a significant addition to our armory to tackle COVID-19 – in addition to our world-renowned vaccination programme and life-saving therapeutics dexamethasone and tocilizumab,” he said.

Developed by US-headquartered Regeneron and Swiss-headquartered Roche, Ronapreve 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 British government has said the focus was now to work at pace with the National Health Service (NHS) to ensure the new treatment can be rolled out to patients as soon as possible. The process for its deployment is to be laid out in the coming weeks.

According to the MHRA, clinical trial data assessed by a dedicated team of its scientists and clinicians has shown that Ronapreve may be used to prevent infection, promote resolution of symptoms of acute COVID-19 infection, and reduce the likelihood of being admitted to hospital due to 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,” Dr Samantha Atkinson, MHRA Interim Chief Quality & Access Officer.

“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,” she said.

The news of the new drug comes as AstraZeneca announced a late-stage study had indicated its antibody therapy met the main goal of preventing COVID-19. The news puts the British-Swedish biopharmaceutical major on track to potentially offer an alternative to vaccines for people with weakened immune systems.