Invivyd’s PEMGARDA™ Treatment Expansion Request Denied by FDA
FDA Denies Invivyd’s Expansion Request for PEMGARDA™
Invivyd, Inc. has faced a setback with the U.S. Food and Drug Administration (FDA) declining its request to expand the emergency use authorization (EUA) for its investigational monoclonal antibody, PEMGARDA™ (pemivibart), to include the treatment of mild-to-moderate COVID-19 in immunocompromised individuals with no other therapeutic options. The existing EUA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients remains effective.
The FDA’s Reasoning Explained
The FDA's reasoning suggests that any treatment for COVID-19 that relies on immunobridging must demonstrate superior antiviral activity compared to previous monoclonal antibody treatments that have been shown to be effective. In this instance, the FDA concluded that the known and potential risks associated with pemivibart do not outweigh its benefits for COVID-19 treatment.
Comparative Analysis Presented by Invivyd
In its submission, Invivyd provided analyses showing that the antiviral activity of pemivibart is comparable to that of adintrevimab, highlighting that both antibodies have demonstrated clinical effectiveness. The study aimed to show that pemivibart could indeed serve as a viable treatment option for patients who are unable to access conventional therapies.
The Impact on Patients
Mark Wingertzahn, Invivyd’s Senior Vice President of Clinical Development, expressed profound disappointment, noting that patients who have no access to standard care will continue to lack effective treatment options. Pemivibart, although authorized for prevention, is now withheld from those infected with COVID-19.
Concerns from Healthcare Professionals
Dr. Alfred H. Kim, an Associate Professor at Washington University School of Medicine, has voiced concerns regarding the inability of healthcare providers to incorporate monoclonal antibody therapy into treatment protocols. Given the current high rates of COVID-19 infections and hospitalizations, especially among vulnerable populations, the lack of a robust treatment option is alarming.
Looking Ahead: Invivyd’s Plans
Moving forward, Invivyd intends to further engage with the FDA to advocate for the inclusion of pemivibart as a COVID-19 treatment. Simultaneously, the company is developing a new candidate, VYD2311, aimed at meeting the ongoing requirements for effective COVID-19 management, especially among immunocompromised individuals.
The Role of VYD2311
VYD2311 represents a new avenue in monoclonal antibody development, engineered from Invivyd’s proprietary technology platform to target contemporary virus lineages effectively. This innovation highlights Invivyd’s commitment to addressing the urgent needs of patients during the ongoing pandemic.
About PEMGARDA™ and Its EUA
PEMGARDA™ (pemivibart) is authorized under emergency use by the FDA for the pre-exposure prophylaxis of COVID-19 in individuals aged 12 and older who are unable to respond adequately to COVID-19 vaccinations due to severe immune compromise. It is essential to note that PEMGARDA is not a treatment for active COVID-19 and is specifically not a substitute for vaccination in recommended individuals.
Safety and Efficacy Profile of PEMGARDA
While PEMGARDA shows promise in neutralizing various SARS-CoV-2 variants, there are considerations regarding anaphylaxis and other adverse events. Patients are monitored closely to ensure its safety and effectiveness in the intended population.
Conclusion
Invivyd continues to strive towards advancing the development and accessibility of innovative treatments for COVID-19, but the recent setback highlights the challenges faced by companies in bringing new therapies to market. The fight against COVID-19 is ongoing, and so is the search for effective treatment options in the face of evolving infections.
Frequently Asked Questions
What led to the FDA's decision to deny Invivyd’s request?
The FDA determined that pemivibart must show superior antiviral activity compared to previous monoclonal antibodies, which Invivyd's submission did not adequately demonstrate.
How does PEMGARDA™ function?
PEMGARDA™ is designed to neutralize SARS-CoV-2 by targeting the spike protein receptor binding domain, preventing the virus from attaching to human cells.
What are the implications of the FDA's decision for patients?
Immunocompromised patients currently lack effective treatment options for mild-to-moderate COVID-19, further complicating their healthcare management.
What new developments is Invivyd pursuing?
Invivyd is developing VYD2311 to address ongoing treatment needs for COVID-19 and plans to continue engaging with the FDA on PEMGARDA.
Who should consider PEMGARDA for COVID-19 prevention?
PEMGARDA is recommended for individuals aged 12 and above with moderate-to-severe immune compromise who cannot mount a sufficient immune response to vaccination.
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