The UK medicines regulator has approved the use of the medicine previously known as REGN-Cov2.
Health Secretary Sajid Javid said the approval of the first treatment designed specifically for Covid-19 in the UK is’ fantastic news’ and he hopes it can be rolled out to NHS patients’ as soon as as possible “.
The Medicines and Health Products Regulatory Agency (MHRA) said data from clinical trials it evaluated showed Ronapreve can be used to prevent infection, treat symptoms of severe infection and reduce the likelihood of being admitted to hospital.
The trials took place before widespread vaccination and before the emergence of viral variants.
This is the first monoclonal antibody combination product approved for use in the prevention and treatment of acute virus infections in the UK.
Monoclonal antibodies are man-made proteins that act like natural human antibodies in the immune system.
The drug, developed by pharmaceutical companies Regeneron and Roche, is given by injection or infusion and works on the lining of the respiratory system where it binds tightly to the virus and prevents it from accessing cells, the MHRA said.
Mr Javid said: ‘The UK is considered a global leader in identifying and deploying life-saving treatments for Covid-19, once they have been proven to be safe and effective in our clinical trials supported by the government.
“This is fantastic news from the independent medicines regulator and it means the UK has approved its first treatment designed specifically for Covid-19.
“This treatment will be an important addition to our arsenal in the fight against Covid-19 – in addition to our world-class vaccination program and our life-saving dexamethasone and tocilizumab therapies.
“We are now working at the pace of the NHS and expert clinicians to ensure this treatment can be rolled out to NHS patients as soon as possible.”
Dr Samantha Atkinson, MHRA Acting Quality and Access Manager, said: “We are delighted to announce the approval of another therapeutic treatment that can be used to help save lives and to protect against Covid-19.
“Ronapreve is the first of its kind for the treatment of Covid-19 and, after careful evaluation of the data by our expert scientists and clinicians, we are confident that this treatment is safe and effective.
“Without any compromise on quality, safety and efficacy, the public can be confident that the MHRA has conducted a solid and in-depth assessment of all available data. “
The health ministry said it would give more details on how the treatment will be rolled out 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 could play “an important role” in help patients most exposed to the virus. , noting that it was administered to Mr. Trump last year.
He said: “The challenge in the future will be to determine which patients should be prioritized for this treatment. Covid is not a rare disease and many people recover on their own after a few days of a nasty flu-like illness.
“It would be difficult to justify giving what will likely be a limited supply of relatively expensive treatment to a large number of people who are likely to improve on their own.
“On the other hand, it can play an important role in patients who are at higher risk of developing a serious infection and who are more likely to end up in the hospital. “
Professor Penny Ward, an independent pharmaceutical physician and visiting professor of pharmaceutical medicine at Kings College London, said it was a “day of good news” and suggested how the drug could be rolled out.
“I think it’s most likely to be used to prevent hospitalization in people who get sick with Covid and who are at a higher risk of needing hospital care / dying from the disease,” said she declared.
She added that it could also be used to prevent Covid infections in people who come in contact with a confirmed case and who might have a reduced response to vaccination, such as those who are being treated for cancer or have undergone transplant.
She suggested that it could also be used to “reduce epidemics” in places like nursing homes, hospitals, prisons and critical workplaces.