March 26, 2024 – The FDA has approved a new antibody treatment to help prevent COVID-19 in those who are most at risk from the virus.
In its announcement, the agency explained that the new treatment can be used preventively for immunocompromised people ages 12 and older who aren’t currently infected with the virus that causes COVID and haven’t recently been exposed.
Called Pemgarda, the monoclonal antibody helps prevent the virus from attaching to human cells and is given through an IV. It cannot be given within 2 weeks of a person receiving a COVID vaccine.
Pemgarda received an emergency use authorization from the FDA. In a letter to drugmaker Invivyd, the FDA requested more data from the ongoing phase III clinical trial studying the drug. Just 1% or fewer people in the study had COVID with symptoms within 90 days of getting Pemgarda, while 5% of people from a control group with healthier immune systems developed the illness, according to early results posted by Invivyd.
The FDA authorization requires close monitoring after the antibody treatment, and Invivyd reported that four people in the clinical trial had anaphylaxis – a severe allergic reaction – either during the IV or afterward. Two incidents were considered life-threatening.
COVID disproportionately affects people who don’t have normal immune systems. A study published in the journal The Lancet in December found that people with compromised immune systems who got COVID accounted for about 1 in 4 COVID hospitalizations, intensive care unit admissions, and deaths. The immunocompromised people were still at increased risk of poor outcomes due to COVID even if they had received three or more doses of COVID vaccines, the researchers found.
The study also showed that the highest risk for hospitalization, ICU admission, or death due to COVID was among people who had received solid organ transplants, have a disorder that weakens their immune system, have received stem cell treatments, or had blood cancer.
Pemgarda may be available within 2 weeks, The New York Times reported.