FDA grants EUA to Invivyd’s PEMGARDA for COVID-19 pre-exposure prophylaxis in immunocompromised individuals
Invivyd, Inc. (Nasdaq: IVVD), a pioneering biopharmaceutical company dedicated to safeguarding vulnerable populations from severe viral infectious diseases, has recently made headlines with the announcement of the U.S. Food and Drug Administration (FDA) granting Emergency Use Authorization (EUA) for PEMGARDA (pemivibart). This groundbreaking treatment, formerly known as VYD222, is a half-life extended monoclonal antibody (mAb) designed for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents aged 12 and older who weigh at least 40 kg and are experiencing moderate-to-severe immune compromise due to specific medical conditions or the receipt of certain immunosuppressive medications or treatments. This EUA marks a significant milestone, especially for individuals unlikely to mount an adequate immune response to COVID-19 vaccination, including those not currently infected or recently exposed to SARS-CoV-2.
Dave Hering, CEO of Invivyd, articulated the transformative impact of PEMGARDA’s EUA, emphasizing its strategic significance and the validation of the company’s innovative platform approach. Developed through Invivyd’s proprietary INVYMAB technology, PEMGARDA is the first of its kind to receive EUA based on a novel and rapid immunobridging trial design, showcasing the potential for repeated innovation in addressing the challenges posed by the fast-paced viral evolution.
The authorization of PEMGARDA is backed by positive data from the CANOPY clinical trial and ongoing in vitro studies demonstrating its neutralizing activity against significant SARS-CoV-2 variants, including JN.1. This approval heralds the immediate availability of PEMGARDA in the U.S., with Invivyd’s recent share sales under its At-the-Market facility further bolstering its financial stability ahead of the product’s launch.
Experts and stakeholders in the medical community have expressed enthusiasm for PEMGARDA. Cameron R. Wolfe, M.B.B.S., M.P.H., from Duke University School of Medicine, highlighted the critical need for additional preventive options for immunocompromised patients, who remain at heightened risk despite vaccination efforts. Similarly, Jorey Berry, President and CEO of the Immune Deficiency Foundation, welcomed this advancement, underscoring the disproportionate impact of COVID-19 on immunocompromised individuals.
The EUA is based on comprehensive scientific evidence, including immunobridging data from the CANOPY trial and neutralizing antibody titers consistent with efficacy seen in prior mAb products. PEMGARDA represents a pivotal development in the ongoing fight against COVID-19, offering hope and protection to some of the most vulnerable populations.
With approximately $200.6 million in cash and cash equivalents as of December 31, 2023, and additional funds raised in February 2024, Invivyd is well-positioned to support PEMGARDA’s launch and further development. The company is planning to explore the protective clinical benefits of mAb prophylaxis for symptomatic COVID-19 disease in future studies, reinforcing its commitment to innovation and the well-being of immunocompromised patients.
This authorization is not only a win for Invivyd but also a beacon of hope for individuals at increased risk of COVID-19. As the battle against the pandemic continues, PEMGARDA stands out as a testament to the power of science, innovation, and collaboration in the pursuit of safeguarding public health.