Xevudy: UK approves new COVID treatment, may work against Omicron
London, Dec 2: The UK's medicines regulator on Thursday approved a new antibody treatment against COVID-19, which it believes will also be effective against new variants such as Omicron.
The Medicines and Healthcare products Regulatory Agency (MHRA) said Xevudy or sotrovimab is for people with mild to moderate COVID-19 who are at high risk of developing severe disease.
Developed by GSK and Vir Biotechnology, sotrovimab is a single monoclonal antibody and the drug works by binding to the spike protein on the outside of the COVID-19 virus. This in turn prevents the virus from attaching to and entering human cells, so that it cannot replicate in the body.
I am pleased to say that we now have another safe and effective COVID-19 treatment, Xevudy (sotrovimab), for those at risk of developing severe illness, said Dr June Raine, MHRA Chief Executive.
This is yet another therapeutic that has been shown to be effective at protecting those most vulnerable to COVID-19, and signals another significant step forward in our fight against this devastating disease. With no compromises on quality, safety and effectiveness, the public can trust that the MHRA have conducted a robust and thorough assessment of all the available data, she said.
Sotrovimab is administered by intravenous infusion over 30 minutes and is approved for individuals aged 12 and above who weigh more than 40 kg. The MHRA said it is too early to know whether the Omicron variant has any impact on sotrovimab's effectiveness, but they plan to work with the manufacturers to establish this.
But based on preliminary lab studies, researchers say the drug targets a part of the spike protein of the virus that has not yet undergone big changes or mutations, meaning it should work well against all variants.
In a clinical trial, a single dose of the monoclonal antibody was found to reduce the risk of hospitalisation and death by 79 per cent in high-risk adults with symptomatic COVID-19 infection. Based on the clinical trial data, sotrovimab is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible and within five days of symptom onset.
When administered in the early stages of infection, sotrovimab was found to be effective at reducing the risk of hospitalisation and death in high-risk individuals with symptomatic COVID-19. Based on the data reviewed by the Commission and its expert group, it is clear sotrovimab is another safe and effective treatment to help us in our fight against COVID-19, said Professor Sir Munir Pirmohamed, Chair of the UK's Commission on Human Medicines.
Like molnupiravir, which is an antiviral pill treatment in use, the new therapy has been authorised for use in people who have mild to moderate COVID-19 infection and at least one risk factor for developing severe illness. Such risk factors include obesity, older age groups of 60 and above, diabetes mellitus, or heart disease.
The MHRA reiterated that sotrovimab is not intended to be used as a substitute for vaccination against COVID-19. Following the approval, the UK's National Health Service (NHS) will confirm how this COVID-19 treatment will be deployed to patients.
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US temporarily suspends all military aid to Ukraine after Trump-Zelenskyy faceoff
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New York/Washington (PTI): US President Donald Trump has temporarily suspended, with immediate effect, the delivery of all American military aid to Ukraine, just days after an unprecedented showdown with Ukrainian President Volodymyr Zelensky in the Oval Office.
A report in The New York Times quoted a senior administration official as saying that Trump temporarily suspended the delivery of all US military aid to Ukraine and that the order takes effect immediately, affecting "more than $1 billion in arms and ammunition in the pipeline and on order”.
The report said Trump’s decision to halt military aid “resulted from a series of meetings” at the White House between the US leader and his senior national security aides.
The official said "the order would be in effect until” Trump determined that Ukraine had demonstrated a commitment to peace negotiations with Russia.
The order also pauses “hundreds of millions of dollars in aid through the Ukraine Security Assistance Initiative, which provides funds that Kyiv can use only to buy new military hardware directly from US defence companies.”
According to the US State Department, Washington has till date provided USD 65.9 billion in military assistance since Russia launched its premeditated, unprovoked, and brutal full-scale invasion of Ukraine on February 24, 2022, and approximately USD 69.2 billion in military assistance since Russia’s initial invasion of Ukraine in 2014.
This latest setback for Ukraine in the third year of its war with Russia comes just days after Trump and Vice President J D Vance had a heated verbal exchange with Zelensky, who was visiting the White House last Friday and the two countries were all set to sign a rare mineral deal.
But talks between Trump and Zelensky unravelled in a heated exchange that played out in front of the global media.
Towards the end of the about 50-minute press conference, Vance told the Ukrainian leader, "I think it's disrespectful for you to come to the Oval Office to try to litigate this in front of the American media. ... you should be thanking the president for trying to bring you into this conference.”
As the conversation grew heated, Trump told Zelenskyy, “You're gambling with the lives of millions of people. You're gambling with World War Three. You're gambling with World War Three, and what you're doing is very disrespectful to the country, this country that's backed you far more than a lot of people say they should.”
Trump and Vance also criticised Zelensky for not being grateful enough for the support that the US had given so far to Ukraine in its war with Russia. As leaders from Europe and around the world took to social media website X to rally behind Zelenskyy and underscore their support for Kyiv, the Ukrainian leader responded to everyone with the same message - “Thank you for your support.”
