Invivyd’s Request for Expanded Use of PEMGARDA™ (pemivibart) for Mild-to-Moderate COVID-19 Denied by FDA
In a recent press release, Invivyd, Inc., a biotechnology company based in Waltham, Massachusetts, announced that the Food and Drug Administration (FDA) has declined their request to expand the Emergency Use Authorization (EUA) for their drug, PEMGARDA™ (pemivibart). The current EUA allows for the use of PEMGARDA™ as a pre-exposure prophylaxis for COVID-19 in certain immunocompromised patients. However, Invivyd had hoped to expand the EUA to include the use of the drug as a treatment option for adults and adolescents with mild-to-moderate COVID-19 and moderate-to-severe immune compromise.
Background on PEMGARDA™
PEMGARDA™ is an intramuscular injection of pemivivimab and impimivimab, two monoclonal antibodies that work together to neutralize the SARS-CoV-2 virus. The drug has been shown to reduce the risk of contracting COVID-19 in immunocompromised individuals by up to 83%. It is currently approved for use as a preventative measure in those at high risk of exposure to the virus, such as healthcare workers and individuals in long-term care facilities.
The Declined Request
The FDA’s decision to decline Invivyd’s request comes after a review of the data submitted by the company. According to the press release, the FDA determined that the data presented did not meet the necessary criteria for expanding the EUA to include treatment of mild-to-moderate COVID-19 in immunocompromised patients. Invivyd plans to continue working with the FDA to provide additional data to support the expanded use of PEMGARDA™.
Impact on Individuals
For individuals with moderate-to-severe immune compromise, the denial of the expanded EUA for PEMGARDA™ may mean that they will continue to have limited treatment options for COVID-19. According to the Centers for Disease Control and Prevention (CDC), people with certain medical conditions, such as cancer and organ transplants, are at higher risk for severe illness from COVID-19. For those who have been relying on PEMGARDA™ as a potential treatment option, the denial of the EUA may be disappointing.
Impact on the World
The denial of Invivyd’s request for expanded use of PEMGARDA™ could have broader implications for the global response to COVID-19. The drug has been shown to be effective in preventing COVID-19 infections in high-risk individuals, and expanding its use to include treatment of mild-to-moderate COVID-19 in immunocompromised patients could have helped reduce the burden on hospitals and healthcare systems. The denial of the EUA may mean that more resources will be needed to develop and approve alternative treatment options for COVID-19 in this population.
Conclusion
The FDA’s decision to decline Invivyd’s request to expand the EUA for PEMGARDA™ to include treatment of mild-to-moderate COVID-19 in immunocompromised patients is a setback for those who were hoping for an additional treatment option for this population. While Invivyd plans to continue working with the FDA to provide additional data, the denial may mean that more resources will be needed to develop and approve alternative treatment options for COVID-19 in immunocompromised individuals. For now, those with moderate-to-severe immune compromise will continue to rely on existing treatment options, which may be limited.
- Invivyd had requested to expand the EUA for PEMGARDA™ to include treatment of mild-to-moderate COVID-19 in immunocompromised patients
- The FDA reviewed the data submitted by Invivyd and determined that it did not meet the necessary criteria for expanding the EUA
- The denial of the EUA may limit treatment options for immunocompromised individuals with COVID-19
- Invivyd plans to continue working with the FDA to provide additional data to support expanded use of PEMGARDA™
