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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ED raids Kolkata Police deputy commissioner, businessman in PMLA probe
Kolkata (PTI): The Enforcement Directorate on Sunday conducted raids at the premises of Kolkata Police Deputy Commissioner Shantanu Sinha Biswas and a local businessman as part of a money laundering probe against an alleged criminal and his linked syndicate in the poll-bound state, officials said.
Two premises of Biswas, including his residence in Ballygunge area and one location of the businessman named Joy Kamdar, Managing Director of a company named Sun Enterprise, have been raided under the provisions of the Prevention of Money Laundering Act (PMLA).
Kamdar has been taken by the officials to the local ED office for questioning. Biswas, chief coordinator and nodal officer of the West Bengal and Kolkata Police welfare committee, was not present at his premises, they said.
The action is linked to a money laundering case against an alleged local criminal named Biswajit Podder alias Sona Pappu, who is booked in multiple cases on charges of attempted murder and extortion.
The federal probe agency had conducted the first round of searches in this case on April 1.
The ED had then seized cash of Rs 1.47 crore apart from gold jewellery and silver valued at Rs 67.64 lakh and a country-made revolver from some premises that were searched.
The probe stems from a Kolkata Police FIR against against Podder for his alleged involvement in rioting, attempt to murder, criminal conspiracy and Arms Act violations. The accused, including Podder, were engaged in organised criminal syndicate activities in the state of West Bengal and generated funds illegally by way of syndicate operations, the ED said in a statement on April 9.
Podder is also wanted by the police in a case of violence in Kankulia road near Golpark of Kolkata and is currently on the run.
The ED has issued summons to Podder but he has failed to join the investigation so far, according to the agency.
West Bengal will have a two phase poll on April 23 and April 29.
