FDA Grants Emergency Use of Pemgarda for Preexposure Prophylaxis of COVID-19

The Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Pemgarda^™ (pemivibart), a long-acting monoclonal antibody, for the preexposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older weighing at least 40 kg. The treatment is authorized for patients who are not currently infected with SARS-CoV-2 and have not had a known recent exposure to an individual infected with SARS-CoV-2; and who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.

Pemgarda is a SARS-CoV-2 spike protein-directed attachment inhibitor. The EUA is supported by immunobridging data (based on the serum neutralization titer-efficacy relationships identified with other neutralizing human monoclonal antibodies against SARS-CoV-2) from the ongoing phase 3 CANOPY trial (ClinicalTrials.gov Identifier: NCT06039449). The study enrolled patients at least 18 years of age into 2 cohorts.

Cohort A (single-arm, open-label trial) included adults with moderate to severe immune compromise who received at least 1 dose of pemivibart. In Cohort B, adults without moderate to severe immune compromise were randomly assigned to receive either pemivibart or placebo.

The primary endpoint of Cohort A was to evaluate protection against symptomatic COVID-19 based on calculated titers against SARS-CoV-2 following pemivibart administration by immunobridging to historical data from the EVADE study (ClinicalTrials.gov Identifier: NCT04859517), which provided evidence of clinical efficacy of adintrevimab, the parent monoclonal antibody of pemivibart.

Results showed the trial met the primary immunobridging endpoint for Cohort A. Calculated serum neutralizing antibody titers against JN.1 (the current dominant variant circulating in the US) were consistent with the titer levels associated with efficacy in prior clinical trials of adintrevimab and certain other monoclonal antibody products previously authorized for the prevention of COVID-19. 

The most common adverse events reported with pemivibart were systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, fatigue, headache, and nausea. Anaphylaxis was observed in 0.6% of study participants. The treatment should only be administered in settings in which health care providers have immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system, as necessary.

Pemgarda is supplied as a 500mg/4mL single-dose vial. Treatment is administered as a 4500mg single IV infusion; dosing may be repeated every 3 months from the date of the most recent dose. The product is expected to be available soon.