Pemivibart will act as an additional preventive option for COVID-19 among moderately-to-severely immunocompromised adult and adolescent patients, who are disproportionally impacted by the condition.
The FDA has granted emergency use authorization (EUA) to pemivibart (Pemgarda) for the pre-exposure prophylaxis (PrEP) of COVID-19 in adults and adolescents 12 years of age and older who weigh at least 40 kilograms with moderate-to-severe immune compromise, according to a release by biopharmaceutical company Invivyd.1 Recipients of pemivibart should not be currently infected or had a recent exposure to an individual infected with SARS-CoV-2.
Intravenous fluid for infusion / Trsakaoe - stock.adobe.com
Pemivibart, formerly VYD222, is the first PrEP monoclonal antibody to receive EUA from the FDA based on a novel, rapid, repeatable, immunobridging trial design. It is also the first authorized monoclonal antibody out of Invivyd’s proprietary platform approach to address the challenge of rapid viral evolution.
Trial Name: A Study to Investigate the Prevention of COVID-19 with VYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
Clinicaltrials.gov Identifier: NCT06039449
Sponsor: Invivyd, Inc.
Summary: A study to investigate the prevention of COVID-19 with VYD222 in adults with immune compromise and in participants aged 12 years or older who are at risk of exposure to SARS-CoV-2.
“The Pemgarda EUA marks a transformational moment for Invivyd and for the many moderately-to-severely immunocompromised people who are vulnerable to COVID-19 disease in the US. This EUA milestone represents strategic proof-of-concept for our company and platform, affirming the unique strategy we embarked on over a year ago: to use rapid innovation and surrogate markers to bring new antibodies to market repeatedly,” said Dave Hering, CEO of Invivyd, in a release.1 “Pemgarda is the first authorized monoclonal antibody from our proprietary platform approach. We are committed to ongoing process improvement while working with global regulatory agencies with the aim to increase the speed and efficiency of the new monoclonal antibody candidate development even further.”
Pemivibart’s authorization was supported by positive results from the phase 3 CANOPY clinical trial (NCT06039449), which demonstrated that immunobridging was established and that the calculated serum neutralizing antibody titers against JN.1—considered the most dominant COVID-19 variant in the US at the time of analysis—aligned with the titer levels associated with efficacy in prior clinical trials of adintrevimab, the parent monoclonal antibody for pemivibart.
READ MORE: Slideshow: COVID-19 Vaccines, Booster Immunity and Emerging Variants
Among 623 participants in CANOPY who received at least 1 dose of pemivibart, 4 (0.6%) people experienced anaphylaxis. The most common side effects were skin reactions at the infusion site, cold and flu-like illness, headache, fatigue, and nausea.2
Research has demonstrated that people with immune dysfunction—even including those who have received multiple doses of a COVID-19 vaccine—face an increased risk of COVID-19-related hospitalization and death compared to the general population.1 Pemivibart will act as an additional preventive option for COVID-19 among moderately-to-severely immunocompromised adult and adolescent patients, who are disproportionally impacted by the condition.
“[Immunocompromised individuals] are less likely to build enough protection against COVID after vaccination. For these patients, the pandemic is not over,” said Scott Roberts, MD, infectious diseases specialist at Yale Medicine, in a release.2 “Hopefully, this new treatment will help the vulnerable feel safer.”
Pemivibart is a medication that targets the spike protein of SARS-CoV-2, the virus that causes COVID-19, and blocks the virus from entering and infecting cells. Pemivibart helps the body develop antibodies against SARS-CoV-2 comparable to the levels seen in non-immunocompromised individuals after vaccination.2 It is administered as an intravenous infusion and can be given as often as every 3 months.1
Made commercially available in the US in April, pemivibart is currently the only PrEP drug for COVID-19 on the market.3 It can be obtained by prescription through a network of authorized specialty distributors. Although the price has not been determined, news reports have suggested it will be covered by Medicare and private insurance plans.2
READ MORE: COVID-19 Resource Center
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