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Highlights
- PEMGARDA™ shows sustained neutralizing activity against the XEC variant, covering 69% of U.S. variants.
- The drug has demonstrated effectiveness against over 75% of circulating U.S. variants, surpassing previous medicines.
- PEMGARDA™ maintains antiviral activity across 39 distinct SARS-CoV-2 variants over almost three years.
Invivyd (NASDAQ:IVVD) has revealed new in vitro neutralization data for PEMGARDA™ (pemivibart), demonstrating the drug’s continued effectiveness against the emerging SARS-CoV-2 variant XEC. This promising data further cements PEMGARDA’s position as a key treatment option in the fight against COVID-19, showcasing consistent neutralizing activity similar to the previously reported KP.3.1.1 variant. According to the U.S. Centers for Disease Control and Prevention (CDC), the XEC and KP.3.1.1 variants accounted for approximately 69% of all circulating SARS-CoV-2 variants in the U.S. as of December 21, 2024.
PEMGARDA™ has proven to be highly effective against a wide range of variants. In addition to its strong neutralization activity against the XEC variant, the drug continues to show robust antiviral effects against over 75% of the current circulating U.S. variants. This includes neutralizing activity against all previously tested variants. The continued success of PEMGARDA™ highlights its potential as a durable treatment option in combating the ever-evolving SARS-CoV-2 virus, which has mutated significantly over nearly three years of circulation.
The data also highlights PEMGARDA's consistency in maintaining antiviral activity across 39 distinct SARS-CoV-2 variants, with minimal reductions in neutralization efficacy compared to older medicines such as Evusheld™. This is particularly significant as many COVID-19 treatments face challenges in retaining effectiveness as the virus mutates. The fact that PEMGARDA™ has shown sustained performance throughout the evolution of the virus reflects its potential as a reliable therapeutic tool.
In response to these promising findings, Invivyd has submitted the new data to the U.S. Food and Drug Administration (FDA), with an update to the PEMGARDA™ Fact Sheet for Healthcare Providers expected. This submission further strengthens the case for PEMGARDA™ as an important addition to the arsenal of COVID-19 treatments. As new variants continue to emerge, the consistent performance of PEMGARDA™ against a wide array of strains could prove critical in mitigating the effects of the ongoing pandemic.
Moreover, the broad antiviral activity demonstrated by PEMGARDA™ is particularly valuable as it is able to maintain its effectiveness despite the extensive genetic changes that have occurred in the virus over time. This sets PEMGARDA™ apart from other therapies that have seen decreased efficacy as variants like XEC and others have become dominant.
In summary, Invivyd’s latest data for PEMGARDA™ offers strong evidence of its ongoing effectiveness in neutralizing current SARS-CoV-2 variants, including the dominant XEC strain. With continued success against 75% of U.S. variants and minimal loss of efficacy compared to its predecessors, PEMGARDA™ represents a promising treatment for COVID-19, showing both long-term durability and broad protection against viral mutations. The company's submission to the FDA and upcoming updates reflect its confidence in the drug’s potential for widespread use in the fight against COVID-19.
