In a first: UK approves treatment of acute Covid with artificial antibodies

Ronapreve 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 United Kingdom’s medicines regulator approved treatment of severe Covid-19 cases using artificial antibodies in a first for the country, shortly after Texas, Florida and Australia approved similar treatments.

The Medicines and Healthcare Products Regulatory Agency approved Ronapreve, a drug developed by Regeneron and Roche, which 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.

According to a press release (https://www.gov.uk/government/news/first-monoclonal-antibody-treatment-for-covid-19-approved-for-use-in-the-uk) by the UK government, clinical trial data has shown that Ronapreve may be used to prevent infection, promote resolution of symptoms of acute Covid-19 infection and can reduce the likelihood of being admitted to hospital due to Covid-19. Monoclonal antibodies are artificial proteins that act like natural human antibodies in the immune system.

Javid termed the development as “fantastic news” and expressed hope that the antibody treatment could be rolled out for patients on the NHS as soon as possible. “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,” he said.

The nod to the treatment comes at a time the UK reported a five-month high of over 6,100 weekly Covid-19 cases and rising hospitalisations. On the same day, Texas Governor Greg Abbott announced that Regeneron’s monoclonal antibody therapy treatment will be available at no cost (https://gov.texas.gov/news/post/office-of-the-governor-statement-on-covid-19-monoclonal-antibody-treatment) to all who get a doctor’s referral. The setting up of nine antibody infusion centres have been set up across Texas, while 140 providers are already providing the treatment at hospitals and clinics across the state.

Meanwhile, Florida Governor Ron DeSantis announced the opening of a fifth monoclonal antibody therapy treatment site, which has an ability to serve over 300 patients daily.

In Australia, GSK Australia and Vir Biotechnology received provisional approval from the Therapeutic Goods Administration (TGA) for sotrovimab, a monoclonal antibody for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus who do not require initiation of oxygen due to Covid-19 and who are at an increased risk of progression to hospitalisation or death.

Ronapreve has received emergency approval for Covid-19 treatment in over 20 countries, including the United States. The University of Oxford said last week that its recovery trials found that for hospitalised patients with severe Covid-19 “who have not mounted a natural antibody response of their own”, Regeneron’s monoclonal antibody cocktail reduces the risk of death by a fifth, compared to those who had received standard care.

Some emerging variants like the Delta Plus “variant of interest” have also displayed the ability to nullify the use of monoclonal antibodies, according to Dr V K Paul, NITI Aayog’s Member-Health and the Chair of the National Expert Group on Vaccine Administration against Covid-19.

(With inputs from agencies)

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