March 26, 2024 – The FDA has approved a brand new antibody treatment to stop COVID-19 in those most in danger from the virus.
In his NoticeThe agency explained that the brand new treatment may be used preventatively for immunocompromised people ages 12 and older who will not be currently infected with the virus that causes COVID and haven’t been recently exposed.
The monoclonal antibody, called Pemgarda, helps prevent the virus from attaching to human cells and is run via an infusion. It can’t be administered inside 2 weeks of receiving a COVID vaccination.
Pemgarda received emergency use authorization from the FDA. In a letter to drugmaker Invivyd, the FDA requested additional data from the continuing Phase III clinical trial evaluating the drug. Only 1% or fewer of study participants had COVID-19 symptoms inside 90 days of contracting Pemgarda, while 5% of individuals in a control group with healthier immune systems developed the disease first results posted by Invivyd.
The FDA permit requires close monitoring after antibody treatment and Invivyd reported that 4 people within the clinical trial experienced anaphylaxis – a severe allergic response – either in the course of the infusion or afterwards. Two incidents were considered life-threatening.
COVID disproportionately affects individuals who should not have normal immune systems. A study published within the journal The lancet In December, it was found that individuals with weakened immune systems who had COVID accounted for about one in 4 COVID hospitalizations, intensive care unit admissions and deaths. The researchers found that the immunocompromised people were still at increased risk of poor outcomes as a result of COVID even in the event that they had received three or more doses of COVID vaccines.
The study also showed that the very best risk of hospitalization, intensive care unit admission or death as a result of COVID was in individuals who had received solid organ transplants, had a condition that weakens their immune system, had received stem cell treatments or had blood cancer Suffer.
Pemgarda could also be available inside 2 weeks. The New York Times reported.