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COVID: UK regulator approves first coronavirus-specific drug for use

The use of the first drug in the UK using man-made antibodies to prevent and tackle coronavirus has been approved by the medicines regulator.

Health Secretary Sajid Javid said approval of the first treatment designed specifically for COVID-19 was “fantastic news” and that he hoped it could be rolled out for patients on the NHS “as soon as possible”.

The Medicines and Healthcare products Regulatory Agency (MHRA) said clinical trial data they had assessed showed Ronapreve may be used to prevent infection, treat symptoms of acute infection and could reduce the likelihood of being admitted to hospital due to the virus.

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The trials took place before widespread vaccination – and the emergence of virus variants.

It is the first monoclonal antibody combination product approved for use in the prevention and treatment of acute infection from coronavirus for the UK.

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

Developed by pharmaceutical firms Regeneron and Roche, the drug 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.

Mr Javid said: “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 would confirm how the treatment would be deployed to patients in due course.

It came as AstraZeneca announced a late-stage study had indicated its antibody therapy met the main goal of preventing COVID.

The news puts the British drugmaker on track to potentially offer an alternative to vaccines for people with weakened immune systems.

The firm said the cocktail of two types of antibodies, initially discovered by Vanderbilt University Medical Center, reduced by 77% the risk of developing symptomatic COVID-19.

More than 75% of the participants had chronic conditions, including some linked to a diminished immune response to vaccination, it said.

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