Covid-19 Antibody Drug by Regeneron Expanded as FDA Nods

The Covid-19 evolutionary mechanism makes it a moving target due to its fast changes. So it is with disease therapies, which can suddenly become fashionable or obsolete. Regeneron’s REGEN-COV antibody cocktail is a good example of the former. Almost every advancement in the Covid-19 antibody market in the previous several months has favoured the treatment, a combination of casirivimab and imdevimab.The FDA approved REGEN-COV for emergency use on Friday as a prophylactic strategy for those who have been exposed to Covid-19 and are at high risk of developing a severe illness because they haven’t been fully vaccinated or aren’t likely to produce a sufficient antibody response to immunisation.

According to Regeneron, about 3% of the US population will not respond fully to Covid-19 vaccinations, including chemotherapy patients, persons with hematologic malignancies, and others. The FDA made its decision based on the results of a phase 3 trial conducted in collaboration with the National Institutes of Health, which showed that REGEN-COV reduced the probability of getting symptomatic Covid-19 by 81 percent among healthy people living with an infected person.

The drug was evaluated in 1,505 people who had spent the previous four days with an infected person. Those who had a REGEN-COV infusion had a 72 percent efficiency rate against symptomatic Covid-19 in the first week and a 93 percent efficacy rate after that. REGEN-COV patients also cleared the infection faster than the placebo group among those who exhibited symptoms.

While it takes time for vaccine recipients to develop an adequate antibody response, especially with a two-shot regimen, direct antibody injections can provide more rapid protection. In November, the FDA approved REGEN-COV for individuals with newly diagnosed Covid-19 who are at a high risk of developing severe disease. Regeneron’s medicine has since received FDA approval for a subcutaneous injection and a lower dose.