FDA authorizes monoclonal antibody therapy for emergency use in some patients 12 and older

The authorization is specifically for those with mild-to-moderate Covid-19, who are at risk of getting much sicker

The US Food and Drug Administration authorized the monoclonal antibody therapy sotrovimab Wednesday for the treatment of some Covid-19 patients ages 12 and older, who are at risk for severe disease or death.

The authorization is specifically for those with mild-to-moderate Covid-19, who are at risk of getting much sicker – not for those who are already hospitalized or on oxygen therapy. Monoclonal antibodies may worsen outcomes for hospitalized Covid-19 patients who require oxygen or mechanical ventilation, the FDA noted.

“This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions,” the FDA wrote in a statement Wednesday.

The FDA cited data from a clinical trial, in which 7% of patients who received a placebo were hospitalized or died, compared to 1% of participants who received sotrovimab – an 85% reduction.

Testing also showed that sotrovimab worked against virus variants first identified in the United Kingdom, South Africa, Brazil, California, New York and India.

“It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

The FDA authorized the treatment to be distributed intravenously by health care providers. Potential side effects include anaphylaxis, rash and diarrhea.

Tags : #FDA #FDANews #MonoclonalAntibodyCovid #Sotrovimab #FDAApprovalNews

About the Author

Team Medicircle

Related Stories

Loading Please wait...


Trending Now

Why is Early Intervention (EI) so important for autism?November 30, 2022
Heart failure – Symptoms, risk factors, and treatmentNovember 30, 2022
How to consume Bulletproof coffee for weight loss?November 30, 2022
MedySeva Gives New Dimension to Affordable TelehealthNovember 29, 2022
A mental healthcare revolution with Trijog November 29, 2022
Health Basix – In-school healthcare partner for your kidsNovember 28, 2022
Health-tech startup Healthkart raises Rs 536.52 Crore led by TemasekNovember 28, 2022
TummyFriendly Foods – Harmless Bio-available nutrition for little onesNovember 28, 2022
Causes, Symptoms, and Solutions to Lung Cancer November 28, 2022
5 reasons behind premature hair grayingNovember 26, 2022
Connect2MyDoctor’s cARe - Augmented Reality tool playing a crucial role in patient educationNovember 26, 2022
Bollywood Actor Kajal Aggarwal invests in D2c Startup TACNovember 26, 2022
Causes, Symptoms, Treatment, and Preventive Solutions for Ovarian Cancer November 26, 2022
Men’s health firm Bonatra raises Rs 5.5 Cr in the pre-seed funding roundNovember 25, 2022
Why is Samantha Ruth Prabhu hospitalized again in Hyderabad?November 25, 2022
RedBrick AI, a Healthtech startup, raises $4.6 million in funding from Sequoia India, Surge.November 25, 2022
Now schedule your health check-ups at a much-discounted price with MediWheelNovember 24, 2022
Kamal Haasan gets admitted to Chennai Hospital Today November 24, 2022
India's first Global Women's Health Innovation Conference to highlight the potential of Femtech & Digital InnovationsNovember 24, 2022
Pred Health - HealthTech Startup dedicated to provide Integrated care management for cancer patientsNovember 24, 2022