Medical Professionals Reference (MPR)FDA Grants Emergency Use of Pemgarda for Preexposure Prophylaxis of COVID-19

The EUA is supported by immunobridging data from the ongoing phase 3 CANOPY trial.

The FDA’s recent Emergency Use Authorization (EUA) of Pemgarda™ (pemivibart) marks a significant advancement in the preexposure prophylaxis of COVID-19 for individuals with moderate to severe immune compromise. This authorization, grounded in the compelling results from the CANOPY trial, underscores the potential of Pemgarda in offering protection against COVID-19, particularly for those unlikely to respond adequately to vaccination.

Key Points:

• The FDA has granted EUA to Pemgarda™ (pemivibart) for the preexposure prophylaxis of COVID-19 in certain adults and adolescents.
• Pemgarda is indicated for individuals who are at least 12 years old, weigh a minimum of 40 kg, and have moderate to severe immune compromise.
• The treatment is designed for those who are not currently infected with SARS-CoV-2, have not been recently exposed to it, and may not mount a sufficient immune response to COVID-19 vaccination.
• Pemgarda functions as a SARS-CoV-2 spike protein-directed attachment inhibitor.
• The EUA is based on immunobridging data from the phase 3 CANOPY trial, which demonstrated efficacy by comparing serum neutralizing antibody titers with those from previous studies.
• The CANOPY trial included two cohorts, with Cohort A focusing on individuals with immune compromise who received pemivibart.
• The primary endpoint was met for Cohort A, showing protection against symptomatic COVID-19 through immunobridging to the EVADE study’s data.
• Adverse events associated with pemivibart included infusion-related reactions, infections, and anaphylaxis in a small percentage of participants.

HCN Medical Memo
Pemgarda is administered via a single IV infusion, with potential repeat dosing every three months. The medication is anticipated to be available shortly and is supplied as a 500mg/4mL single-dose vial.

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