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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BJP won't cross 50-mark in Bengal polls, says TMC in response to Shah's 'two-thirds majority' claim
Kolkata (PTI): The Trinamool Congress on Tuesday hit back at Union Home Minister Amit Shah, accusing him of peddling falsehoods and making baseless claims about securing a two-thirds majority in the 2026 West Bengal Assembly elections.
Senior TMC leader and state education minister Bratya Basu told reporters that Shah's remarks were based on hollow assertions and claimed that the BJP would not even cross the 50-seat mark in the polls.
"Shah will keep coming and going like a tourist. Such visits will serve no purpose," Basu said on the sidelines of a programme.
"The BJP will not even cross the 50-mark in the assembly polls and suffer a humiliating defeat," Basu claimed.
Addressing a press conference here, Shah claimed that the BJP would form the next government in the state with a "two-thirds majority in 2026".
"We will not only identify infiltrators, but we'll also drive them out. Bengal will have a new BJP government after April 15, 2026, as people have made up their minds," he said.
Shah also took a dig at the Trinamool Congress government on the issue of women's safety.
"It has been officially stated that women should not step out of their homes after 7 pm. What era are we living in? Are we living in the Mughal period?," he said.
"Mamata ji, this is a free India. Ensuring that women can step out safely whenever they choose is a constitutional right. Your government has failed to provide this basic security," he added.
Criticising Shah over his comments on women's safety in the state, senior TMC leader and minister Sashi Panja urged the Union home minister to visit Bengal during the festive season, like Durga Puja and Christmas, when thousands of women move about freely and participate in festivities.
"In case a stray incident happens, our administration takes prompt action to bring the culprits to book. Instead, the rapists of Bilkis Bano are garlanded by your party activists. Your party shields Kuldeep Sengar and Brij Bhusan, who were accused of committing atrocities. Amitji should not lecture on women's security," she said.
Panja accused Shah and his party at the Centre of coming in the way of the passage of the Aparajita Bill, which would have ensured exemplary punishment to rapists after conviction.
On Shah's claims about the industrial decline of Bengal, Panja said since 2011, investment of Rs 13.8 lakh-crore came to the state.
"Bengal occupies the second berth in the MSME sector as per the figures available with the Centre, and he is peddling falsehood about the industrial growth of Bengal," she said.
TMC spokesperson Jay Prakash Majumdar also dismissed Shah's assertion that the BJP does not engage in temple-based polarising politics.
"Everyone knows the BJP campaigned on temple-masjid politics in both the 2019 and 2024 elections. This brand of politics will again be rejected by the people of Bengal," Majumdar said.
