New Covid treatment Xevudy approved by UK drugs watchdog

The MHRA has authorised Xevudy for people with mild to moderate illness at high risk of severe disease. Photograph: GlaxoSmithKline/PA

The UK's medicines regulator has approved a new Covid medication after trials shown that it significantly reduces the likelihood of hospitalization and mortality in high-risk patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Xevudy (sotrovimab), a monoclonal antibody developed by GlaxoSmithKline (GSK) and Vir Biotechnology, for the treatment of patients with mild to moderate Covid-19 who are at high risk of developing severe disease.

According to GSK and Vir Biotechnology, preclinical findings indicate that the medicine "retains activity against key mutations in the new Omicron Sars-CoV-2 variant."

The UK government has placed an order for around 100,000 doses of the medication. It is the MHRA's second monoclonal antibody approval, following Ronapreve.

Dr. June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency, said: "I am pleased to announce the availability of another safe and effective Covid-19 therapy, Xevudy (sotrovimab), for people at risk of developing severe sickness.

"This is yet another therapeutic that has been demonstrated to be effective in protecting those most susceptible to Covid-19, and represents another significant step forward in our fight against this deadly disease."

The medicine acts by attaching to the coronavirus's spike protein on the exterior. This stops the virus from adhering to and infecting human cells, preventing replicating in the body.

According to clinical trials, the medicine is most effective when administered during the initial stages of illness. As a result, the MHRA recommended that it be used as soon as feasible and within five days after the onset of symptoms.

The medicine has been approved for mild to moderate Covid-19 infection and at least one risk factor for severe disease. These include being obese, over the age of 60, having diabetes, or having heart disease.

Xevudy is licensed for use in people aged 12 and older and is delivered via intravenous infusion over 30 minutes. The MHRA stated that it collaborated with the firm to determine the drug's efficacy against the new Omicron strain.

"Sotrovimab was purposefully designed with a mutating virus in mind," stated George Scangos, chief executive of Vir.

"This hypothesis has been validated repeatedly, as evidenced by its ongoing ability to maintain activity against all tested variants of concern and interest to date, including key mutations discovered in Omicron."

Ministers acquired an additional 114 million Covid-19 vaccinations from Pfizer and Moderna for possible booster campaigns over the following two years.

Annual immunizations against Covid-19, according to Pfizer's CEO, are likely to be required. According to Dr. Albert Bourla, annual injections could help enhance population immunity, and the company is already developing a new vaccine for the Omicron type.

"Based on everything I've seen thus far, I'd say that annual vaccinations... are likely to be required to maintain a very robust and very high level of protection," he told the BBC.

Bourla further stated that vaccines aided in saving millions of lives during the epidemic and that their absence would jeopardize the "fundamental structure of our society."

Publish : 2021-12-02 17:17:00

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