Wednesday, February 1, 2023
Home COVID-19 Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19

Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19

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At present, the U.S. Meals and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody remedy sotrovimab for the remedy of mild-to-moderate COVID-19 in adults and pediatric sufferers (12 years of age and older weighing no less than 40 kilograms [about 88 pounds]) with optimistic outcomes of direct SARS-CoV-2 viral testing and who’re at excessive danger for development to extreme COVID-19, together with hospitalization or dying. This consists of, for instance, people who’re 65 years of age and older or people who’ve sure medical situations.

The security and effectiveness of this investigational remedy continues to be evaluated for remedy of COVID-19. Sotrovimab shouldn’t be licensed for sufferers who’re hospitalized resulting from COVID-19 or require oxygen remedy resulting from COVID-19. This remedy has not proven profit in sufferers hospitalized resulting from COVID-19 and monoclonal antibodies could also be related to worse scientific outcomes when administered to hospitalized sufferers requiring excessive movement oxygen or mechanical air flow.

“With the authorization of this monoclonal antibody remedy, we’re offering an alternative choice to assist maintain high-risk sufferers with COVID-19 out of the hospital,” stated Patrizia Cavazzoni, M.D., director of the FDA’s Heart for Drug Analysis and Analysis. “It is very important develop the arsenal of monoclonal antibody therapies which are anticipated to retain exercise towards the circulating variants of COVID-19 in the US.” 

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s potential to battle off dangerous antigens equivalent to viruses. Sotrovimab is a monoclonal antibody that’s particularly directed towards the spike protein of SARS-CoV-2 and is designed to dam the virus’ attachment and entry into human cells.

The issuance of an EUA is totally different than FDA approval. In figuring out whether or not to problem an EUA, the FDA evaluates the totality of accessible proof and thoroughly balances any identified or potential dangers with any identified or potential advantages of the product to be used throughout an emergency. Primarily based on the FDA’s overview of the totality of the scientific proof accessible, the company decided that it’s affordable to imagine that sotrovimab could also be efficient in treating adults and sure pediatric sufferers with mild-to-moderate COVID-19. And, when used to deal with COVID-19 for the licensed inhabitants, the identified and potential advantages outweigh the identified and potential dangers for the drug. There are not any satisfactory, authorised and accessible different remedies to sotrovimab. 

The information supporting this EUA for sotrovimab are primarily based on an interim evaluation from a part 1/2/3 randomized, double-blind, placebo-controlled scientific trial in 583 non-hospitalized adults with mild-to-moderate COVID-19 signs and a optimistic SARS-CoV-2 take a look at consequence. Of those sufferers, 291 acquired sotrovimab and 292 acquired a placebo inside 5 days of onset of COVID-19 signs. The first endpoint was development of COVID-19 (outlined as hospitalization for larger than 24 hours for acute administration of any sickness or dying from any trigger) by day 29. Hospitalization or dying occurred in 21 (7%) sufferers who acquired placebo in comparison with 3 (1%) sufferers handled with sotrovimab, an 85% discount.

The FDA is fastidiously monitoring circulating viral variants and their sensitivity to monoclonal antibodies licensed to deal with COVID-19, together with sotrovimab. Laboratory testing confirmed that sotrovimab retains exercise towards the present circulating variants first reported in the UK, South Africa, Brazil, California, New York and India. 

The EUA permits for sotrovimab to be distributed and administered as a 500 milligram single dose intravenously by well being care suppliers. The EUA requires that truth sheets that present essential details about utilizing sotrovimab in treating COVID-19 be made accessible to well being care suppliers and to sufferers, dad and mom and caregivers, together with dosing directions, potential unwanted side effects and drug interactions. Potential unwanted side effects of sotrovimab embrace anaphylaxis and infusion-related reactions, rash and diarrhea. 

The EUA was issued to GlaxoSmithKline.

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The FDA, an company inside the U.S. Division of Well being and Human Companies, protects the general public well being by assuring the security, effectiveness, and safety of human and veterinary medication, vaccines and different organic merchandise for human use, and medical units. The company is also accountable for the security and safety of our nation’s meals provide, cosmetics, dietary dietary supplements, merchandise that give off digital radiation, and for regulating tobacco merchandise.


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