Health Secretary Sajid Javid said approval of the first drug designed specifically for COVID-19 in the country is “fantastic news” and he hopes it can be rolled out for patients on the NHS “as soon as possible.”
The Medicines and Healthcare products Regulatory Agency (MHRA) said the clinical trial data they had assessed has shown Ronapreve may be used to prevent infection, treat symptoms of acute COVID-19 infection, and can reduce the likelihood of being admitted to hospital due to the virus.
Trials took place before widespread vaccination and before the emergence of virus variants.
The drug, previously known as REGN-Cov2, was given to former U.S. President Donald Trump when he was admitted to hospital with COVID-19 last year.
It is the first monoclonal antibody combination product approved for use in the prevention and treatment of acute infection from the virus for the UK.
Monoclonal antibodies are man-made proteins that act like natural human antibodies in the immune system.
The drug, developed by pharmaceutical firms Regeneron and Roche, is given either by injection or infusion, and acts at the lining of the respiratory system where it binds tightly to the virus, and prevents it from gaining access to the cells, the MHRA said.
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 regulator said the government and NHS will confirm how the treatment will be deployed to patients in due course.
Professor Martin Landray, professor of medicine and epidemiology at the Nuffield Department of Population Health, University of Oxford, said the approval is “an important step forward” and that it could play “an important role” in helping patients at higher risk from the virus.
He said: “The challenge going forward will be in determining which patients should be prioritised for this treatment. COVID is not a rare disease and many people get better of their own accord after a few days of a nasty flu-like illness.
“It would be hard to justify giving what are likely to be limited supplies of a relatively expensive treatment to huge numbers of people who are likely to get better on their own.
“On the other hand, it may play an important role in patients who are at higher risk of developing severe infection and who are more likely to end up in hospital.”
By Aine Fox