FDA Grants Emergency Authorization for Invivyd’s Pemgarda Antibody Prophylactic Against COVID-19 in Immunocompromised Individuals

- The FDA granted emergency use authorization to Invivyd Inc.'s Pemgarda for the pre-exposure prophylaxis of COVID-19 in adults and adolescents with moderate to severe immune compromise.
- Pemgarda demonstrated high serum virus-neutralizing antibody titer levels against XBB.1.5 in Phase 3 CANOPY trial cohorts.
- In interim exploratory data from the CANOPY trial, VYD222 arm saw a 0% proportion of participants with RT-PCR-confirmed symptomatic COVID-19 compared to 3% in placebo among those without moderate-to-severe immune compromise at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interaction.
- Among participants with moderate-to-severe immune compromise, the proportion of participants with RT-PCR-confirmed symptomatic COVID-19 after a median 35 days follow-up was 0% in the VYD222 group versus 1% in the placebo group.
- Evusheld, previously available as an antibody treatment, had been pulled off the market by the FDA in January 2023 due to its ineffectiveness against new Omicron variants.
- Pemgarda can be re-dosed every three months to increase patients’ antibody levels.