The US Food and Drug Administration (FDA) has granted Invivyd’s Pemgarda (pemivibart) emergency use authorisation (EUA) for the prevention of COVID-19 in adults and adolescents aged 12 and older, weighing at least 40kg.
The FDA has authorised the long-acting monoclonal antibody (mAb) for patients who are currently not infected with SARS-CoV-2 or who have no known recent exposure and have moderate-to-severe immune compromise due to certain medical conditions or certain immunosuppressive medications or treatments that are unlikely to mount an adequate immune response to the COVID-19 vaccination.
The FDA’s decision was based on data from the ongoing phase 3 CANOPY trial, which enrolled patients aged 18 years and over into two cohorts: A and B.
Results showed that cohort A, a single-arm, open-label trial involving adults with moderate-to-severe immune compromise who received a single dose of Pemgarda, met the primary immunobridging endpoint and demonstrated that the calculated serum neutralising antibody titers against JN.1, a currently-circulating SARS-CoV-2 variant in the US, were consistent with the titer levels linked with the efficacy of previous trials evaluating adintrevimab, the parent mAb for Pemgarda, and other mAb products.
Invivyd is expecting to have Pemgarda available for order immediately, with supply already packaged and awaiting final release from its US-based third-party provider, explained Dave Hering, chief executive officer, Invivyd.
Hering continued: “Pemgarda is the first authorised mAb from our proprietary platform approach [and] we are committed to ongoing process improvement while working with global regulatory agencies… to increase the speed and efficiency of new mAb candidate development even further.
“Additionally, we are planning to explore the protective clinical benefits of mAb prophylaxis for symptomatic COVID-19 disease in future studies.”
Immunocompromised individuals have a weakened immune system and have a reduced ability to fight infections and other diseases, including COVID-19.
“These types of patients, among others, continue to have both an impaired response to vaccines and a higher risk for severe COVID-19 outcomes,” said Cameron Wolfe, professor of medicine, transplant infectious disease, Duke University School of Medicine.