FDA Grants Approval For The Emergency Use Of A Monoclonal Antibody In The Treatment Of Covid-19

FDA Grants Approval For The Emergency Use Of A Monoclonal Antibody In The Treatment Of Covid-19

In another step towards winning the battle against Covid-19, GSK and Vir Biotechnology Inc together have got the authorization to introduce a monoclonal antibody – sotrovimab.

FDA Grants Approval For The Emergency Use Of A Monoclonal Antibody In The Treatment Of Covid-19

This is the third antibody treatment that is approved as an emergency-use by the US-Food and Drug Administration (US-FDA) after casirivimab and imdevimab developed by Regeneron Pharmaceuticals Inc in collaboration with Eli Lilly. These antibodies can be administered together for the treatment of covid-19. 

Monoclonal antibodies are those that can mimic the natural antibodies that the body generates to fight the virus. In this case, the three antibodies that are approved by the FDA have the ability to mimic the antibodies that are generated in the body when it gets infected with Covid-19.

Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, held a news conference to announce this news to the world. He was the acting director when he approved the use of the first two monoclonal antibodies for covid-19 treatment.

Even though the cases in the US are in decline with the introduction of the vaccine, this line of treatment is important as the other parts of the world are still grippling with mutant variants of the virus. Sotrovimab is said to help in neutralizing the mutant variants which are prevalent in India as well as those seen in Brazil, Britain, and South Africa.

Cavazzoni, in the press release, said that these antibodies are also useful in the US where it can act as another option to treat high-risk patients to prevent hospitalization. It could certainly prevent the burden on the hospitals which were drowned in patients with little to no amenities to treat the patients last year. It could also help to treat any mutant variants that may arise in the future, as said by the Vir’s chief executive, George Scangos

Just like the first two antibodies, Sotrovimab can also be administered in people aged 12 and older and only to patients that are non-hospitalized with mild to moderate symptoms and not to hospitalized patients and to those that require oxygen therapy.  

Not only the US FDA but even the European Union’s drug regulator- European Medicines Agency(EMA) backed the claims of Sotrovimab in the treatment of Covid-19. Even Health Canada initiated the review of the drug. This shows that the antibody has strong hopes in showing better results in the clinical trials which were conducted with 583 volunteers with mild symptoms which started within five days. The antibody developed by GSK-Vir showed a good result of an 85% reduction in hospitalization/ death as compared to placebo.  There were mild adverse effects which included rash and diarrhoea but no other serious events.  But health officials still warn of anaphylaxis reactions that might occur in certain patients when administered. 

This approval could also be called a milestone because it navigates the problem faced by the concoction antibodies of Regeneron Pharmaceuticals Inc and Eli Lilly, which require i.v administration. Also, on the real-world use, their antibodies showed little effect on the mutant variants seen in South Africa and Brazil, which was reported by the New York Times whereas the new antibody showed results against mutant strains. 

Dr. Hal Barron, chief scientific officer and president of R&D, GSK, was happy with their collaboration for the clinical trials and was positive about the results. Along with their partner Vir, they were working towards making sotrovimab available to US patients in the coming weeks and also were in talks with global regulators to help introduce the drug in a global market so that all patients could get their hands on the treatment.

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