The U.S. Food and Drug Administration (FDA) authorized Regeneron’s COVID-19 antibody cocktail to be used as a preventive treatment on Friday.
The combo therapy, REGEN-COV, was approved in November 2020 for emergency use to treat people with mild-to-moderate COVID-19 cases in the U.S.
But the expanded authorization now enables the drug to also be used a prophylactic for patients who are at high risk of exposure in settings such as nursing homes or prisons.
It could also help reduce the risk of infection for those with weakened immune systems including those with HIV, organ transplant patients and people suffering from autoimmune diseases
The FDA approved Regeneron’s antibody cocktail REGEN-COV (above) to also be used as a preventive treatment against COVID-19 for those at high risk of exposure in settings such as nursing homes who who are high risk because they have weakened immune systems
Trial data released in April by Regneron above) showed the drug reduced the risk of symptomatic infections by 72% in the first week, and 93% after that
The antibody cocktail, REGEN-COV, is a combination of two drugs: casirivimab and imdevimab.
Both are monoclonal antibodies that target the the spike protein, which the virus uses to enter and infect cells.
These cocktails deliver virus-fighting antibodies into the body unlike traditional vaccines in which the receiver’s immune system is activated to develop its own antibodies.
According to trial data released in April, the drug reduced the risk of symptomatic infections by 72 percent in the first week, and 93 percent after that,
What’s more, it lowered the risk of symptomatic infections by 81 percent when used by those who were exposed to household individuals that had the virus.
Additionally, researchers found the cocktail reduced the risk of infection by 76 percent among patients considered high risk of becoming severely ill.
When used by among those who did develop symptoms, the treatment group cleared the virus faster than those in the placebo group.
Regeneron said the expanded authorization will help address the needs of immunocompromised people, including those taking immunosuppressive medicines, whose bodies may not mount an adequate response to COVID-19 vaccination.
Nobody treated with REGEN-COV group developed serious side effects such as as life-threatening allergic reaction.
Dr Myron Cohen, a professor of epidemiology at the University of North Carolina at Chapel Hill and one of the researchers studying Regeneron’s cocktail as a prevention method said the drug is most protective while the virus is the nose and throat.
‘It’s a race between your ability to make an antibody to protect your lungs and the rest of your body and the virus,’ he told NBC News.
‘And if you’re likely to lose the race, you’re the person for whom these antibody drugs are appropriate.’
In its statement announcing the authorization, the FDA said the expanded approval is not a substitute for vaccination.
The federal health agency said any American should get immunized against the disease.
Source link : https://www.dailymail.co.uk/health/article-9845333/FDA-okays-Regeneron-COVID-19-antibody-preventive-high-risk-settings.html
