FDA Rejects Expansion of EUA for Pemgarda (Pemivivart) for Mild-to-Moderate COVID-19
On Monday, the Food and Drug Administration (FDA) announced its decision to decline Invivyd, Inc.’s request to expand the existing emergency use authorization (EUA) for the use of Pemgarda (pemivivart) as a pre-exposure prophylaxis (PrEP) for mild-to-moderate COVID-19 in adults and adolescents with moderate-to-severe immune compromise. This decision comes as a setback for those who were hoping for an expanded use of the drug to help prevent COVID-19 infections in high-risk populations.
Background
Pemgarda is an intramuscular injection of pemivivart, a monoclonal antibody therapy, developed by Invivyd, Inc. The drug was granted EUA by the FDA in December 2021 for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older) who are at high risk for progression to severe COVID-19, including hospitalization, or death. The EUA was based on data from clinical trials showing the drug’s safety and efficacy in treating COVID-19.
The Request for Expansion
Invivyd, Inc. had requested the FDA to expand the EUA to include the use of Pemgarda as a PrEP for mild-to-moderate COVID-19 in adults and adolescents with moderate-to-severe immune compromise. The company submitted data from a Phase 2/3 clinical trial, which showed that the drug reduced the risk of developing symptomatic COVID-19 by 85% in this population. The trial involved over 2,500 participants and was conducted in the United States, Europe, and South America.
The FDA’s Decision
Despite the promising results of the clinical trial, the FDA stated that the data did not provide sufficient evidence to support the safety and efficacy of Pemgarda as a PrEP for mild-to-moderate COVID-19 in this population. The FDA’s decision was based on the lack of data on the long-term safety of the drug, as well as the limited information on the durability of the protective effect against COVID-19. The FDA also expressed concerns about the potential for antibody-dependent enhancement of COVID-19, which could increase the risk of severe disease.
Implications for Individuals
For individuals with moderate-to-severe immune compromise, this decision may mean that they will continue to rely on other preventive measures, such as vaccination, social distancing, and masking, to protect themselves from COVID-19. Those who have already received Pemgarda as a treatment for COVID-19 may still benefit from its protective effect for a period of time. However, more research is needed to determine the durability of the protective effect and the potential for long-term safety.
Implications for the World
The FDA’s decision to decline the EUA expansion for Pemgarda as a PrEP for mild-to-moderate COVID-19 in adults and adolescents with moderate-to-severe immune compromise may have implications for the global response to the pandemic. This population, which includes people with cancer, transplant recipients, and those with HIV/AIDS, among others, is at high risk for severe COVID-19 and may benefit from preventive measures. The lack of an approved PrEP for this population may delay the return to normalcy for some communities and may increase the burden on healthcare systems.
Conclusion
The FDA’s decision to decline Invivyd, Inc.’s request to expand the EUA for Pemgarda as a PrEP for mild-to-moderate COVID-19 in adults and adolescents with moderate-to-severe immune compromise is a setback for those who were hoping for an additional tool to prevent COVID-19 infections in this population. However, it is important to remember that the FDA’s primary responsibility is to ensure the safety and efficacy of medical products. More research is needed to determine the long-term safety and durability of the protective effect of Pemgarda as a PrEP for COVID-19. In the meantime, other preventive measures, such as vaccination, social distancing, and masking, remain crucial in protecting individuals and communities from COVID-19.
- FDA declines Invivyd, Inc.’s request to expand EUA for Pemgarda as a PrEP for mild-to-moderate COVID-19
- Data from a Phase 2/3 clinical trial showed an 85% reduction in risk of developing symptomatic COVID-19 in high-risk population
- FDA cites concerns over long-term safety and potential for antibody-dependent enhancement
- Individuals with moderate-to-severe immune compromise may continue to rely on other preventive measures
- Lack of approved PrEP for this population may delay return to normalcy and increase burden on healthcare systems
